91-79-BDP-PBR-PCS-ART-170201-PharmAlliance Brochure PDF

Where Expectations Meet Expertise
© Copyright 2015 ● PharmAlliance ● All rights reserved.
Contents
 About PharmAlliance
 A Comprehensive Menu of Services… Designed for Results…
 Country / Services Matrix
 Conceptualization and Design of Manufacturing, Testing, and R&D Facilities
(New or Upgrading)
 Quality Systems Development & Implementation
 Worldwide Regulatory Affairs Consulting Services
 cGXP (GMP, GLP, GCP) Audits
 Approvals for Generic Pharmaceuticals
 Master Files for Active Pharmaceutical Ingredients
 Certificates of Suitability to the Monographs of the
European Pharmacopoeia (CEP or COS)
 US Type IV and Canadian Type III Drug Master Files for Excipients,
IPEC Excipient Master Files
 US Type III and Canadian Type II Drug Master Files for Packaging Materials
 Support Services for Preclinical, Clinical and Bioequivalence Studies
 Reference Listed Drugs (RLDs)
 Approvals for Medical Devices
 Electronic Regulatory Submissions
 Submissions to the US FDA’s Electronic
Drug Registration and Listing System (eDRLS)
 Product Labeling
 Training and Education
 Business Development Consulting Services
 Contract Manufacturing, Testing, Product Development,
Preclinical, and Clinical Research Arrangements
 Our Team
 Panel of Experts
 Our Contact Information
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Unit 401, Ashirwad Complex, Opp. Sardar Patel Sewa Samaj Hall, Mithakhali, Ellis Bridge, Ahmedabad 380006, India
Tel: +91 (79) 2646-1411 e-mail: info@pharmalliance.com Web: www.pharmalliance.com
© Copyright 2015 ● PharmAlliance ● All rights reserved. ⌂BACK TO CONTENTS

Mission
PharmAlliance is committed to supporting the business development of
the pharmaceutical and related industries by providing
complete and comprehensive scientific, technical, quality and regulatory expertise
for achieving global market presence.
PharmAlliance is a knowledge driven, Our client base comprises of a cross-section

independent, professional consultancy firm, of reputable large, medium and small
dedicated to serving the pharmaceutical, companies in the pharmaceutical,
biopharmaceutical, API (active pharmaceutical biopharmaceutical, API, medical device, and
ingredient), excipient, medical device, and allied excipient industries from several countries,
industries in the “regulated”, and other including India, USA, Canada, Europe, Australia,
emerging markets around the rest of the world. China, Latin America, and Africa (including South
Africa), who we have successfully assisted in
Since its inception in January, 2000, various ways for winning regulatory approvals
PharmAlliance has an outstanding track and to establish international market presence.
record for providing complete, end-to-end,
Our approach is uniquely designed to focus on
highly specialized and tailor-made consulting
keeping on top of market, technological and
services.
regulatory developments, as well as building
effective relationships with regulatory agencies,
healthcare and related product manufacturers
 CONCEPTUALIZATION AND DESIGN OF cGXP (GMP, and distributors around the world.
GLP, GCP) COMPLIANT MANUFACTURING, TESTING,
AND R&D FACILITIES (NEW OR UPGRADING) Our experts come from an impressive variety of
backgrounds, including top-level positions in
 DEVELOPING AND IMPLEMENTING cGXP
COMPLIANT QUALITY SYSTEMS
R&D, project engineering, manufacturing,
quality assurance, regulatory affairs, pre-clinical
 cGXP AUDITS and clinical research, government regulatory
 INTERNATIONAL REGULATORY AFFAIRS agencies, international business development,
CONSULTING FOR ACHIEVING FACILITY AND and academia. Our cumulative experience in
PRODUCT APPROVALS IN THE USA, CANADA, these areas of expertise totals well over 400
EUROPE, AUSTRALIA, NEW ZEALAND, BRICS, WHO years.
(GENEVA) AND MANY OTHER COUNTRIES AND
REGIONS PharmAlliance has strong international links
 SUPPORT SERVICES FOR PRE-CLINICAL, CLINICAL, with technological, manufacturing, regulatory,
AND BIOEQUIVALENCE STUDIES contract research, and marketing organizations
in several countries. Our global reach extends
 TRAINING AND EDUCATION
from USA and Canada to Europe, Latin America,
 STRATEGIC PLANNING FOR INTERNATIONAL South Africa, Australia, India, China, and other
BUSINESS DEVELOPMENT (PATENT CONSULTING, countries.
PRODUCT / MARKET SELECTION, REGULATORY
STRATEGY DEVELOPMENT, FEASIBILITY STUDIES) Our extensive expertise and solid foundation in
 CONTRACT MANUFACTURING, TESTING, R&D our areas of specialization allows us to provide
ARRANGEMENTS FOR OUTSOURCING our clients with highly skilled individual
attention, and professional and confidential
service in the most efficient and cost-effective
manner. We guarantee performance, integrity
PharmAlliance is the first and the only company and quality combined with a personal
in India (and one of the very few in the world) commitment.
providing such synergistic and integrated
services. FULL SERVICE… INTERACTIVE PROCESS… SUCCESSFUL PROJECTS

A Comprehensive Menu of Services… Designed for Results…
A wealth of expertise is available to you from PharmAlliance in India and our associates in Europe, USA, Canada,
China, and other countries. We customize extremely cost-effective service packages to meet your exact needs,
which can shorten your time to market… and keep you up to speed.
 Detailed User Requirement Specifications (URS)

 Conceptualization and Preliminary Designs
 Project Feasibility Reports
 Equipment Selection
 Detailed Engineering Design (architectural / structural)
SET-UP OF
 HVAC Systems
NEW FACILITIES  Utilities, Water Systems and Plumbing Systems
OR  Electrical, Mechanical, and Fire-Fighting Systems
UPGRADING OF  Effluent Treatment Systems
EXISTING  Final Design - Facility Master Plan
 Validation Master Plan
FACILITIES
 Documented Standards
 Standard Operating Procedures (SOPs), Operating Instructions, Work Instructions
 Master and Batch Production & Control Records
 Quality Assurance Procedures and Documentation
QUALITY  Records and Reports
SYSTEMS
 FDA (USA)
 TPD (Canada)
 EDQM, EMA, European National Authorities including MHRA (UK)
 TGA (Australia)
 MEDSAFE (New Zealand)
FACILITY  ANVISA (Brazil)
 MCC (South Africa)
APPROVALS
 WHO (Geneva)
 ASEAN Regulatory Authorities
 USA: Drug Master Files (DMF), Biologics Master Files (BMF) New or Abbreviated New Drug
Applications (NDA, ANDA), Biologics License Applications (BLA), 510(K) Submissions, eDRLS
Submissions (Establishment Listing, NDC Labeler Code, SPL)
 Canada: Drug Master Files (DMF), New or Abbreviated New Drug Submissions / Supplementals
(NDS / SNDS, ABNDS / SABNDS), Medical Device Pre-Market Review Dossiers, DIN Applications,
Drug Establishment License (DEL) Applications
 Europe: Active Substance Master Files (ASMF), EDQM Certificates of Suitability (CEP), Full or
Abridged Marketing Authorization Applications (MAA), Medical Device CE Mark
 Australia: TGA Registrations for APIs, New and Generic Drugs
 New Zealand: MEDSAFE New Medicine Applications (NMA) for New and Generic Drugs, New
PRODUCT Related Product Applications (NMRP)
APPROVALS  Brazil: ANVISA Drug Master Files for APIs, Product Registration Dossiers (PRD) for New and
Generic Drugs
 South Africa: MCC Registrations for APIs, New and Generic Drugs
 WHO (Geneva): Active Pharmaceutical Ingredient Master Files (APIMF), FPP & IVD
Prequalification Dossiers, Vaccine Product Summary Files (PSF)
 ASEAN Common Technical Document (ACTD)
 Strategic Planning for International Business Development

 Patent Screening
 Product / Market Selection
 Regulatory Strategy Development
INTERNATIONAL  Sponsor Identification (for DMFs, ASMFs, APIMFs)
MARKET  Contract Manufacturing, Testing and Research Arrangements
 Marketing and Distribution Arrangements
PRESENCE
© Copyright 2015 ● PharmAlliance ● All rights reserved.
Country / Services Matrix

Project cGXP cGXP Regulatory Preclinical, RLDs Business
Services Services: Quality Audits: Submissions: Clinical, Development &
Systems Bio- Contract
Manufacturing Development equivalence Manufacturing,
Testing, R&D and 1st 3rd Types Electronic Study Testing,
Facilities Training Party Party Sub- Support R&D,
Design mission and
Mock Services
Countries / and Inspection
Product
Regions Development Development
Arrangements
CTD / eCTD
Type II DMF
(API,  - -
Intermediates & eCTD
Drug Product)
Type III DMF
(Packaging  - -
Materials) eCTD
Type IV DMF  - -
(Excipients) eCTD
Type V DMF
(Reference  - -
Information) eCTD
BMF
(Biologics  - -
Master File) eCTD
IND
(Investigational   -
New Drug eCTD
Application)
NDA
(New Drug   -
Application) eCTD
ANDA
1. USA     (Abbreviated  
New Drug eCTD
 
Application)
BLA
(Biologics   
License eCTD
Application)
510(K)
Submissions
(Medical Device  - -
Premarket
Notification)
eDRLS:
Drug
Establishment  - -
Registration
eDRLS:
NDC Labeler  - -
Code Request
eDRLS:
SPL
Drug Product
Listing  - -
(NDC Number
Application)

Design mission and
Mock Services
Product
Arrangements
CTD / eCTD
Type I DMF 
(API & API - -
Intermediates) eCTD *
Type II DMF 
(Packaging - -
Materials) eCTD *
Type III DMF 
(Excipients) - -
eCTD *
Type IV DMF
(Dosage Forms 
- -
& Drug Product
Intermediates)
eCTD *
NDS / SNDS
(New / 
Supplemental  -
New Drug eCTD *
Submission)
ABNDS /
SABNDS
2. CANADA     (Abbreviated 
New / 
 
Supplemental
Abbreviated
eCTD *
New Drug
Submission)
NC
(Notifiable * - -
Change)
Pre-Market
Review Dossier
(Medical * - -
Devices)
DEL
(Drug
Establishment - - -
License
Application)
DIN Applications
(Drug
Identification
- - -
Number)
* Using the CESG (Common / US FDA Electronic Submissions Gateway)

Design mission and
Mock Services
Product
Arrangements
CTD / eCTD / NeeS

CEP (COS)
EUROPEAN (EDQM
ECONOMIC Certificate of 
Suitability eCTD, - -
AREA (EEA) for NeeS
APIs and
Austria, Excipients)
Belgium,
ASMF (EDMF)
Bulgaria,
Croatia,
(European 
Republic of
Active eCTD, - -
Substance NeeS
Cyprus,
Master File)
Czech Republic,
Denmark, Centralized,
Estonia, Decentralized,
Finland, Mutual
France, Recognition
Germany, and National 
Greece, Full MAA eCTD,  -
Hungary, (European NeeS
3. Ireland,     Marketing 
Italy, Authorization
Latvia, Application –
Lithuania, New Drug)
Luxembourg, Centralized,
Malta, Decentralized,
Netherlands, Mutual
Poland, Recognition
Portugal, and National 
Romania, Abridged MAA eCTD,  
Slovakia, (European NeeS
Slovenia, Marketing
Spain, Authorization
Sweden, Application –
UK, Generic Drug)
Iceland Medical Device
Liechtenstein, Approval Filings - - -
Norway, (CE Mark)
Switzerland
IPEC:
Excipient  - -
NeeS
Master File
RUSSIA CIS
4. AND     Registration -   
CIS Dossiers

Design mission and
Mock Services
Product
Arrangements
CTD / eCTD / NeeS

TGA
Registration
Process and 
Dossiers eCTD,  
(for APIs, NeeS
New Drugs and
AUSTRALIA Generic Drugs)
& MEDSAFE
5.     NMA 
NEW
(New Medicine 
ZEALAND Application – eCTD,  
NeeS
for New Drugs and
Generic Drugs)
MEDSAFE
NRPA 
(New Related eCTD,  -
Product NeeS
Application)
MCC
Registration
SOUTH Dossiers 
6.
AFRICA
    (for APIs, eCTD,   
New Drugs and NeeS
Generic Drugs)
REST OF
AFRICA
Algeria,
Egypt,
7. Ethiopia,      -   
Kenya,
Morocco,
Nigeria
Tanzania,
Uganda
ANVISA
DMF 
(Drug Master eCTD, - -
Files for APIs) NeeS
8. BRAZIL     PRD 
(Product
Registration 
Dossiers eCTD,  
NeeS
for New Drugs and
Generic Drugs)

Facilities Design Training Party Party Sub- Support R&D,
and mission and
Mock Services
Countries / Development Inspection
Product
Regions Development
Arrangements
REST OF
LATIN
AMERICA
Argentina,
Chile,
9. Colombia,      -   
Cuba,
Ecuador,
Guyana,
Mexico,
Peru,
Venezuela
ASEAN
Brunei,
Cambodia, ACTD
Indonesia, ASEAN
Laos, Common Technical
10. Malaysia,
    Document
-   
Myanmar, Registration
Philippines, Dossier
Singapore,
Thailand,
Vietnam
SFDA-CFDA
Registration
11. CHINA     Dossiers -   
(for Drugs and
Medical Devices)
12. INDIA      -   
REST OF
ASIA
Afghanistan,
Bangladesh,
13. Iran,      -   
Iraq,
Jordan,
Nepal,
South Korea,
Sri Lanka

Design mission and
Countries / and Mock Services Product
Inspection
Arrangements
MIDDLE
EAST
GULF
COOPERATION
COUNCIL
14. Bahrain,      -   
Kuwait,
Oman,
Qatar,
Saudi Arabia,
UAE
Prequalification of
Medicines - - -
(PQP):
FPP Dossiers
(CTD)
(for Finished   
NeeS
Pharmaceutical
Products)
APIMF
(CTD)
WHO (Active  - -
15.
(GENEVA)
    Pharmaceutical NeeS 
Ingredient Master
File – for APIs)
Prequalification
of IVDs  - -
(Dossier for NeeS
In Vitro Diagnostics)
Prequalification
of Vaccines:
PSF  - -
(Product Summary NeeS
File for Vaccines)
Conceptualization and Design of Manufacturing,

Testing, and R&D Facilities (New or Upgrading)
A New Dimension to
Project Services…
The Need… …and Our Response

The pharmaceutical industry in developing PharmAlliance has taken the initiative to meet
nations has already recognized the impending this need of the industry by providing integrated
threat of reduction in global market share due to project consulting services, both for setting up of
challenges thrown up by the WTO product new, state-of-the-art manufacturing, testing,
patent regime, and the need to enhance its and research & development (R&D) facilities as
global reach by penetrating developed markets well as modernization of existing facilities, to
such as North America and Europe. Faced with conform to the most rigid international cGXP
mounting national, as well as international (GMP, GLP, GCP) norms.
regulatory and market pressures, setting up of
state-of-the-art manufacturing, testing, and PharmAlliance’s project consulting expertise
development facilities, and modernizing of has a completely new dimension, to provide
existing facilities to meet stringent international the most integrated and efficient package of
regulatory compliance standards has become services.
imperative for the industry.
PharmAlliance integrates first-hand knowledge
On the other hand, the dramatic growth of of worldwide regulations and highly specialized
generic drugs in the “regulated markets”, and conceptualization, design, and project
indeed, all over the world, has opened up new management skills for the creation of
opportunities to industry players. Companies in state-of-the-art manufacturing, testing,
North America and Europe have begun to and R&D facilities.
conduct a significant portion of their
You can rely on us for complete and
manufacturing, testing and R&D activities in the
comprehensive expertise (including
developing nations, particularly India and China,
project / engineering consulting services)
either by way of outsourcing, or partnering with
for conceptualizing and designing of cGXP
local firms in these countries, who have the
compliant manufacturing, testing, or research
infrastructure and capability of meeting
facilities (new or upgrading) and developing
stringent regulatory requirements.
in-house quality systems to achieve cGXP
approvals or certifications from regulatory
Industry players who look to the future, and agencies such as the FDA (USA), EDQM, EMA,
invest in creating such facilities are sure to EU national authorities, TPD (Canada), TGA
achieve long-term profits through contract (Australia), MEDSAFE (New Zealand), ANVISA
manufacturing, testing, or research (Brazil), MCC (South Africa), the WHO (Geneva),
arrangements or joint ventures. ASEAN regulatory authorities, and others.
WE OFFER INTEGRATED PROJECT SERVICES FOR:
 Active Pharmaceutical Ingredients (APIs)

(Non-sterile, Sterile)
 API Intermediates
 Pharmaceuticals and Biopharmaceuticals

(Non-sterile, Sterile)
 Oral Dosage Forms: Tablets, Capsules, Liquid Orals, etc.
 Parenterals: Large Volume and Small Volume
 Ophthalmics &
Dermatologicals: Liquids, Creams, Ointments, etc.
 Excipients (Non-sterile, Sterile)
 Medical Devices and Disposables (Non-sterile, Sterile)
 R&D / Product Development and Testing Facilities:

 Product Development Facilities
 Preclinical and Clinical Research Facilities
 Analytical Testing Facilities
If you are looking for end-to-end expertise to  Project Management: Periodic checking and
set up a new facility, or modernize your existing monitoring of:
facility to achieve international regulatory
 Building Construction
compliance, then we can assist you with:
 Equipment Installation, Qualification,
 Complete Conceptualization and Designing and Commissioning activities
or Redesigning of your Facilities suitable to
the identified location or existing facilities,  Facility Design Qualification and Risk
including selection / deployment of: Analysis Reports
 Machinery / Equipment  Development of a Validation Master Plan
 Utilities: HVAC Systems, Water Systems, (VMP)
Steam, Compressed Air, Gases, Plumbing
 Development and implementation of cGXP
Systems, Electrical Systems, Mechanical
compliant Quality Systems, Documentation
Systems, Fire-Fighting Systems, Effluent
(including SOPs), and training of personnel
Treatment Systems, etc.
to achieve regulatory compliance for the
 Contractors and related service providers target markets / countries.
All our services are provided under strict confidentiality agreements


Avoid an endless cycle of queries and replies at the cost of market opportunities...
Expertise… Experience… Excellence… PharmAlliance…
Quality Systems Development & Implementation
“The requirements of good manufacturing, laboratory and clinical

practices are underpinned by a central objective:
To create a system of programs, policies, processes, and facilities
that prevent errors and defects.”
PharmAlliance has the experience and the (c) Records and Reports
expertise to provide customized solutions that
will put your company in the fast lane to success. Records and Reports provide the documented
evidence that the objectives defined in the
Our expertise can ensure that you are able to standards were achieved by performing all
avoid product recalls, detentions and import actions exactly as laid down in SOPs / Operating
bans which would hinder the growth prospects Instructions / Work Instructions. Record
of your company, create serious financial documentation should be designed in such a
setbacks and stagnate your company in this way that it facilitates the documentation of all
highly competitive industry. actions at the time of performance, as
mandated by worldwide regulations.
The quality documents essential for cGXP (GMP,
PharmAlliance believes in providing best-in-class
GLP, GCP) compliance can be broadly divided
solutions for your company so that your
into three categories:
company meets the latest regulatory norms and
requirements.
(a) Documented Standards
We can help you in developing quality systems
Standards are imperative when exact and
that cover all operational and functional areas,
consistent results are required to be achieved,
and provide the necessary training to implement
time after time. Standards should be clearly
and streamline your operations and
documented, and should, wherever possible,
documentation systems in order to consistently
have measurable parameters.
produce high quality results and to ensure that
your facilities meet and exceed the expectations
(b) Standard Operating Procedures (SOPs) /
of regulatory authorities worldwide.
Operating Instructions / Work Instructions
PharmAlliance’s integrated approach in
Standard Operating Procedures / Operating
developing and implementing quality systems
Instructions / Work Instructions (SOPs) define
specific to your facilities, operations and
exactly how all actions are to be performed in a
products will enable you to achieve cGXP
standardized manner to achieve the objectives
approvals / certifications from regulatory
as laid down in the standards.
agencies such as the FDA (USA), EMA, EDQM,
In order to ensure that meaningful standards are European national authorities, TPD (Canada),
developed, it is also necessary to have TGA (Australia), MEDSAFE (New Zealand),
procedures established describing how to go ANVISA (Brazil), MCC (South Africa), the WHO
about setting the standards. (Geneva), ASEAN regulatory authorities, and
others worldwide.


Worldwide Regulatory Affairs Consulting Services
 cGXP (GMP, GLP, GCP) Audits

 cGXP Compliance (Quality Systems, SOPs, and Record Keeping)
 Preparation and / or Review of Regulatory Submissions
 Support Services for Preclinical, Clinical, or Bioequivalence Studies
 Validation and Analytical Support Services
 Quality, Non-clinical and Clinical Summaries
 Regulatory Affairs Representation and Liaison Services on behalf of clients
PharmAlliance provides comprehensive advice on required to be included in regulatory submissions.

international regulatory compliance requirements This includes complete chemistry, manufacturing
for your facilities and operations, develops and and control (CMC) data as well as preclinical,
implements Quality Systems, procedures, and clinical or bioequivalence data for preparation of
record-keeping systems that will ensure that your regulatory submissions or registration dossiers in
facilities comply fully with cGXP, which will enable the CTD, eCTD or alternative (national) formats
you to successfully face customer audits or intended to be filed in worldwide markets, ranging
regulatory inspections, and achieve cGXP from the high dollar volume “regulated” markets,
approvals or certifications from agencies such as to the rapidly growing markets of Asia and Latin
the FDA (USA), EDQM, EMA, EU national America.
authorities, TPD (Canada), TGA (Australia),
MEDSAFE (New Zealand), ANVISA (Brazil), MCC We specialize in ensuring crystal clear
(South Africa) the WHO (Geneva), ASEAN documentation that will result in a faster,
regulatory authorities, and others worldwide. smoother, more cost-efficient approval process
from start to finish.
We provide our clients with expert advice and Typical examples of the regulatory submissions
complete guidance for generating the relevant that we can prepare and handle are listed in our
scientific, technical and analytical data that is Country / Services Matrix.
 PharmAlliance has first-hand knowledge of worldwide pharmaceutical regulations.

 PharmAlliance provides insight into how regulatory agencies think and what data they
will need to approve specific products.
 PharmAlliance clarifies regulatory issues, anticipates potential problems, and gets
products to approval through the fastest and most direct route possible
 PharmAlliance has extensive experience in interacting with FDA (USA), TPD (Canada),
EMA, EDQM and EU National Authorities including MHRA (UK), TGA (Australia),
MEDSAFE (New Zealand), ANVISA (Brazil), MCC (South Africa), the WHO (Geneva),
ASEAN, and other regulatory agencies worldwide.
Worldwide Regulatory Affairs Consulting Services…

cGXP (GMP, GLP, GCP) Audits
There have been a growing number of cases This can provide executives and shareholders
over the past few years where pharmaceutical the security and knowledge that there will be
and allied manufacturers, as well as contract little or no chance of any surprises because of
testing, R&D, and preclinical and clinical research such deficiencies.
organizations have been cited by various
regulatory authorities for deficiencies in cGXP Third Party Audits
compliance of their manufacturing, testing or
research facilities, in spite of having satisfied Many companies have routine third-party audit
numerous inspections from FDA (USA), EMA, programs where an independent organization
EDQM, European national authorities, TPD verifies that a company’s physical facilities,
(Canada), TGA (Australia), MEDSAFE (New systems and processes meet the appropriate
Zealand), ANVISA (Brazil), MCC (South Africa), standards and regulations.
the WHO (Geneva), ASEAN authorities, and We offer third-party audits to provide companies
others. worldwide with fresh insight into the state of
The discovery of such deficiencies has resulted in compliance of their facilities, operations, and
utterly disastrous consequences for those procedures via an independent unbiased review
companies not only commercially, but also in of areas that need improvement.
terms of their reputation.
Having a third-party auditing program helps
First Party Audits (Clients’ Own Facilities) to reduce non-conformances and regulatory
actions, and prevents poor product quality, loss
Global regulatory agencies require of facility or product approvals, suspensions of
manufacturers, analytical testing laboratories, certifications or registrations, and minimizes
R&D / product development facilities and product liability risks.
preclinical and clinical research organizations to
conduct internal audits to verify the suitability of Contractor and Vendor Audits
their Quality Management Systems (QMS).
PharmAlliance assists worldwide clients in
For clients who do not have a sufficient number locating joint venture partners and / or contract
of in-house qualified personnel to conduct manufacturing, testing, product development,
internal audits, PharmAlliance offers preclinical and clinical research facilities for
comprehensive audit programs for periodic outsourcing in the rapidly developing Asian
assessment of clients’ own facilities, which will markets, conducts cGXP audits of these facilities,
minimize or even totally eliminate the risk of any and monitors them for regulatory compliance on
deficiencies in complying with relevant cGXP behalf of clients.
regulations worldwide.
We perform qualification audits of contract
PharmAlliance can conduct an in depth analysis
facilities used for manufacturing, testing,
of practices in clients’ facilities to assess in detail
packaging and labeling, and distribution of drug
whether all regulatory compliance requirements
products, drug substances (APIs), excipients,
are being met and maintained, and can advise if
packaging materials, and medical devices. We
any corrective action needs to be taken, thus
also audit contract R&D / product development,
providing complete confidence in meeting all
preclinical and clinical research facilities.
expectations of global regulatory authorities.


Who do we audit?
• Pharmaceutical and Biopharmaceutical Manufacturing
Facilities
• API and API Intermediate Manufacturing Facilities
• Excipient Manufacturing Facilities
• Packaging Material Manufacturing Facilities
• Medical Device Manufacturing Facilities
• Repackaging, Warehousing and Distribution Facilities
• R&D / Product Development Facilities
• Contract Analytical Testing Facilities
• Preclinical and Clinical Research Organizations (CROs)
How do we audit?
PharmAlliance conducts all audits with reference to the following main regulations and guidelines as
well as all other regulations and guidelines specifically applicable to the facilities to be audited:
 21 Code of Federal Regulations Parts 210 and 211:

“Part 210 - Current Good Manufacturing Practice in Manufacturing, Processing, Packing,
or Holding of Drugs; General” and “Part 211 - Current Good Manufacturing Practice for
Finished Pharmaceuticals”
 EudraLex Volume 4: Good manufacturing practice (GMP) Guidelines Parts I - III:

“Principles and Guidelines of Good Manufacturing Practice In Respect of Medicinal
Products for Human Use and Investigational Medicinal Products for Human Use”
 World Health Organization:

WHO Expert Committee on Specifications for Pharmaceutical Preparations 32nd Report:
“Good Manufacturing Practices for Pharmaceutical Products”
 ICH Harmonised Tripartite Guideline Q7:

“Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients”
 International Pharmaceutical Excipients Council:

“The Joint IPEC-PQG Good Manufacturing Practice Guide for Pharmaceutical Excipients”
 21 Code of Federal Regulations Subchapter – H: Medical Devices, Part 820:

“Quality System Regulation”
 European Union “Medical Device Directive”:

AIMDD 90/385/EE, MDD 93/42/EEC, IVDMDD/98/79/EC
 21 Code of Federal Regulations: Part 58:

“Good Laboratory Practice for Nonclinical Laboratory Studies”
 ICH Harmonised Tripartite Guideline E6(R1): “Good Clinical Practice”

 ICH Harmonised Tripartite Guideline Q8(R2): “Pharmaceutical Development”
 ICH Harmonised Tripartite Guideline Q9: “Quality Risk Management”
 ICH Harmonised Tripartite Guideline Q10: “Pharmaceutical Quality System”

Approvals for Generic Pharmaceuticals
Get away from other highly competitive markets and tap the multi-billion dollar North
American, European and other regulated generic markets…
 USA: Abbreviated New Drug Applications (ANDA)
 Canada: Abbreviated New Drug Submissions (ABNDS)
 Europe: Abridged Marketing Authorization Applications (AMAA)
 Australia: TGA Registration Dossiers
 New Zealand: MEDSAFE New Medicine Applications (NMA)
 Brazil: ANVISA Product Registration Dossiers (PRD)
 South Africa: MCC Registration Dossiers
 WHO (Geneva): Finished Pharmaceutical Product (FPP)
Prequalification Dossiers
 ASEAN: Asian Common Technical Documents (ACTD)
A generic drug is the same as the original (i.e., performs in the same manner as the
innovator drug in terms of active ingredient(s), innovator drug).
dosage form, safety, strength, route of
administration, performance, and intended use. Once approved, an applicant may manufacture
and market the generic drug product in any of
Generic drugs provide a safe, effective, low cost the countries in which approval is granted.
alternative to the innovator’s original branded
product. PharmAlliance assists clients in rectifying
manufacturing facilities and quality systems to
All of the countries comprising the “regulated” ensure that the subsequent phases of the generic
pharmaceutical markets have established approval application process are carried out in a
elaborate and stringent regulations and cGMP compliant environment. We provide
procedures for approval of generic drug products. comprehensive advice throughout the product
development, data generation, document
Generic drug approval applications are called preparation, rectification and review phases for
“abbreviated” or “abridged” because they are all types of generic drug approval applications,
generally not required to include preclinical
and guide clients throughout the submission
(animal) and clinical (human) data to establish
safety and effectiveness. (electronic or paper) and post-submission
regulatory processes, including responses to
Instead, a generic applicant must scientifically deficiency letters (if any) for resolving queries to
demonstrate that its product is bioequivalent, the satisfaction of the regulatory authorities.
BENEFITS:
 Getting approvals for your generic drug products in these countries can put your
company on the world map of the pharmaceutical industry, enhance your prestige and
reputation, and give you an edge over competitors in any part of the world.
 Penetrating these high entry-barrier markets means lesser competition, better price
realizations, more sales revenues, and sustained long-term profits.
 You will find it easier to gain market entry into many other countries that insist on
allowing only imports of products that have been previously approved in these markets.
SERVICES:
 Information on Reference Drugs and Acceptable Generic Equivalents, and assistance in
procurement of Reference Drug Product Samples
 Locating US and Canadian DMF, European ASMF (EDMF), EDQM CEP (COS), WHO APIMF
sources for Active Ingredients, Excipients and Packaging Materials
 Preparation of US and Canadian DMF, European ASMF (EDMF), EDQM CEP (COS) Dossier,
WHO APIMF for client’s own API(s)
 cGMP Audits and Rectification of Deficiencies in Manufacturing Facilities, Operations,

Quality Systems and Documentation
 Complete Regulatory Compliance guidance for meeting cGMP expectations of FDA (USA),
TPD (Canada), EMA or EEA National Authorities, TGA (Australia), MEDSAFE (New Zealand),
ANVISA (Brazil), MCC (South Africa), the WHO (Geneva), ASEAN regulatory authorities,
and others
 Complete guidance for preparation of CTD / eCTD or NeeS documentation for ANDA,
ABNDS, Abridged MAA, TGA Registrations, MEDSAFE NMA, ANVISA PRD, MCC
Registrations, WHO FPP Prequalification Dossiers, and ASEAN ACTD documentation.
 Arranging Validation and Analytical Support Services
 Assistance in auditing and selection of CROs for Bioequivalence Studies acceptable to US
FDA , TPD Canada, EMA or EEA Regulatory Authorities, TGA (Australia), MEDSAFE (New
Zealand), ANVISA (Brazil), MCC (South Africa), WHO (Geneva) and ASEAN Regulatory
Authorities
 Preparation / Review of all CTD Modules 1-5, conversion to the eCTD or NeeS format for
electronic submission
 Preparation of CTD Summaries (Module 2): Quality Overall Summary, Non-clinical
Overview, Clinical Overview, Non-clinical Summary, Clinical Summary
 Appointment of Regulatory Agent(s) / Qualified Person(s)
 Submission of ANDA, ABNDS, Abridged MAA, TGA Registration Dossiers, MEDSAFE NMA,
ANVISA PRD, MCC Registration Dossiers, WHO FPP Prequalification Dossiers and ASEAN
ACTD to the relevant authorities
 Pre-inspection cGMP Audits
 Liaison with Regulatory Authorities / Regulatory Agent(s) / Quality Person(s)
 Responses to Deficiency Letters
 Supplementals / Variations / Amendments to Applications



Master Files for Active Pharmaceutical Ingredients
Tap worldwide markets for your APIs and enhance your global market reach
for long-term profits…
 USA: Type II Drug Master Files (DMF)

 Canada: Type I Drug Master Files (DMF)
 Europe: Active Substance Master Files (ASMF)
or European Drug Master Files (EDMF)
 WHO (Geneva): Active Pharmaceutical
Ingredient Master Files (APIMF) for the
API Prequalification Program
Any application for approval of a new or a or articles used in the manufacturing,

generic drug product is required to include full processing, packaging, and storing of the active
details of the chemistry, manufacturing pharmaceutical ingredient.
processes and controls of the active ingredients
used in the manufacture of the finished dosage Filing these documents for your APIs with the
form. Very often, dosage form manufacturers do regulatory authorities of USA, Canada, Europe,
not have full access to information that is the WHO (Geneva) and many other regulatory
considered to be confidential, proprietary, or a authorities around the world is a prerequisite for
trade secret by the manufacturer of an active selling your products to pharmaceutical
ingredient. companies in these markets.
A DMF, or ASMF (EDMF) or APIMF is a document PharmAlliance assists clients in rectifying

prepared by an active pharmaceutical ingredient manufacturing facilities and quality systems,
manufacturer and submitted directly to the data generation, document preparation and
appropriate regulatory authority in the intended review. We guide clients throughout the
drug market. The document supports a submission (electronic or paper) and post-
pharmaceutical dosage form manufacturer’s submission regulatory processes, including
application for approval by authorizing the responses to deficiency letters (if any) for
regulatory authority to review confidential, resolving queries to the satisfaction of the
detailed information about facilities, processes, regulatory authorities.
BENEFITS:
 Supplying to customers in these markets can put your company on the world map of the
pharmaceutical industry, enhance your reputation and prestige, and give you an edge
over your competitors in any part of the world.
SERVICES:

 Complete Regulatory Compliance guidance for meeting the ICH Q7 guideline requirements
and cGMP expectations of FDA (USA), TPD (Canada), EMA or European National
Authorities, TGA (Australia), MEDSAFE (New Zealand), ANVISA (Brazil),
MCC (South Africa), the WHO (Geneva), ASEAN regulatory authorities, and others
 Preparation of DMFs, ASMFs (EDMFs), APIMFs, in the CTD format, conversion to the
eCTD or NeeS format for electronic submission
 Review of DMFs / ASMFs (EDMFs) / APIMFs prepared by your staff before filing
 Preparation of Quality Overall Summary
 Appointment of Regulatory Agent(s) / Qualified Person(s)
 Submission of DMFs / ASMFs (EDMFs) / APIMFs to the relevant authorities in CTD (paper),
eCTD or NeeS (electronic) formats
 Sponsor Identification
 Letters of Authorization / Access
 Liaison with Regulatory Authorities / Regulatory Agent(s) / Qualified Person(s)
 Annual Reports (USA)
 Major / Minor Revisions and Updates



Certificates of Suitability to the Monographs of the
European Pharmacopoeia (CEP or COS)
From the European Directorate for the Quality of Medicines and Healthcare (EDQM)
Certify your Active Pharmaceutical Ingredients (APIs) and Excipients in Europe

and increase your exports…
The term CEP stands for Certification of

Suitability of European Pharmacopoeia
monographs to control an active
pharmaceutical ingredient or a
pharmaceutical excipient. The term “COS”,
even if often used for Certificate of
Suitability, is not the official acronym.
A CEP can be obtained for any API or Excipient unified procedure, and is independent of any
that has a monograph in the European Marketing Authorization Application (MAA).
Pharmacopoeia by manufacturers, whatever
their nationality, (or the duly authorized Once granted, this Certificate can be included in
representatives of these manufacturers) of lieu of an ASMF (EDMF) in European MAA
organic and inorganic pharmaceutical active dossiers for all medicines that contain the API or
substances and excipients, obtained by Excipient in question. Only a copy of the
synthesis, extraction, or fermentation, and Certificate needs to be provided to the
products concerned by TSE (Transmissible Marketing Authorization Applicant.
Spongiform Encephalopathies).
The Certificate is recognized by all EU Licensing
The main purpose of the CEP process is to assess Authorities, and is valid for 5 years initially. After
and conclude suitability of the European the expiration of the first 5-year period, a single
Pharmacopoeia monographs to control the one-time renewal is required, following which
chemical purity, microbiological quality and TSE the Certificate remains indefinitely valid, subject
risk (if relevant) for any substance covered by to any changes in facilities, manufacturing or
the monographs, and to check compliance at testing processes being duly communicated to
the manufacturing and / or distribution site(s) EDQM and approved.
covered by CEPs, with both Good Manufacturing
Practice (GMP) for medicinal products for PharmAlliance assists clients in rectifying any
human or veterinary use and with the CEP deficiencies in manufacturing facilities and
granted according to the information submitted quality systems, data generation, document
in the application dossier for a CEP. preparation and review. We guide clients
throughout the submission (electronic or paper)
An application for a CEP can be made directly to and post-submission regulatory processes,
EDQM by submitting a single, confidential including responses to deficiency letters (if any)
dossier to EDQM for evaluation under a and resolving queries to the satisfaction of
EDQM until Certification.
BENEFITS:
 Certification of your APIs or Excipients by EDQM puts your company on the world map of
the pharmaceutical industry, enhances your reputation and prestige, and gives you an
edge over your competitors in any part of the world.
 Certificates are valid in 30 European Pharmacopoeia Commission member countries and

partially accepted in 27 observer countries
 One-time centralized approval, 5–year validity, one time renewal after expiration of the
first 5 year period and indefinite validity thereafter
 Substitute for European Active Substance Master Files
 Growth in global market share, better price realizations, and sustained long-term profits
SERVICES:
 Complete Regulatory Compliance guidance for meeting the ICH Q7 guideline requirements
and cGMP expectations of EDQM
 Preparation of CEP Application Dossiers in the CTD format, conversion to the eCTD or NeeS
format for electronic submission
 Review of Application Dossiers prepared by your staff before filing
 Filing of Applications at EDQM in CTD (paper), eCTD or NeeS (electronic) formats on behalf
of Clients as their Authorized Contact for the complete CEP process and follow-up with
EDQM until Certification is achieved
 Responses to Deficiency Letters, if any
 Major / Minor Changes / Amendments
 Renewal of Certification



US Type IV and Canadian Type III Drug Master Files
for Excipients / IPEC Excipient Master Files
Tap worldwide markets for your Excipients and enhance your
global market reach for long-term profits…
Excipients are substances other than the API which have been
appropriately evaluated for safety and are intentionally
included in a drug delivery system for the purpose of bulking-
up formulations that contain potent active ingredients, or to
confer a therapeutic enhancement on the active ingredient in
the final dosage form, such as facilitating or modifying drug
release, absorption or solubility, or to impart other
organoleptic properties such as color, flavor, or taste-
masking.
Any application for approval of a new or a to review confidential, detailed information
generic drug product (NDA, ANDA, NDS, ABNDS) about facilities, processes, or articles used in the
is required to include full details of the manufacturing, processing, packaging, and
chemistry, manufacturing processes and storing of pharmaceutical excipients, or can
controls of the excipients used in the provide the necessary information to a dosage
manufacture of the finished dosage form. form manufacturer for inclusion in their dossiers.
Most other regulatory agencies around the Filing these documents for your excipients with
world also require such information about the FDA and TPD is a prerequisite for selling your
Excipients to be included in applications for drug products to pharmaceutical companies in these
product approvals or registrations. markets.
Excipient manufacturers can prepare and file
PharmAlliance assists clients in rectifying any
Type IV DMFs (for USA) and Type III DMFs (for
deficiencies in manufacturing facilities and
Canada), and submit them directly to the FDA or
quality systems, data generation, document
TPD respectively. It is also a good idea to
preparation and review. We guide clients
prepare an Excipient Master File (EMF) as per
throughout the submission (electronic or paper)
the International Pharmaceutical Excipients
and post-submission regulatory processes,
Council (IPEC) recommended guidelines. These
including responses to deficiency letters (if any)
documents support a pharmaceutical dosage
for resolving queries to the satisfaction of the
form manufacturer’s NDA or ANDA, or NDS, or
FDA and TPD.
ABNDS by authorizing the regulatory authority
BENEFITS:
 Due to importance of excipients in pharmaceutical formulation development for
international markets, most dosage form manufacturers prefer to buy from holders of US
Type IV DMFs, Canadian Type III DMFs or IPEC Excipient Master File (EMF). Having a DMF or
an EMF for these regions gives you more market coverage and additional business.
 Filing these documents with the regulatory authorities of US, Canada and other regions gives
you an added advantage for selling your products to pharmaceutical companies who are
looking to file for regulatory approvals of their products in these regions.
SERVICES:
 Complete guidance on US FDA / TPD / IPEC cGMP Compliance
 Preparation of US Type IV DMF, Canadian Type III DMF and Excipient Master Files
as per relevant regulatory guidelines and conversion to electronic format for
electronic submissions
 Review of DMFs prepared by your staff before filing
 Appointment of Regulatory Agent(s)
 Submission of US Type IV DMFs, Canadian Type III DMFs and Excipient Master Files
 Liaison with Regulatory Authorities / Regulatory Agent(s)



US Type III and Canadian Type II Drug Master Files
for Packaging Materials
A primary packaging material is that material which is in direct

contact with the product, and the same material also holds the
product. The function of primary packaging materials is to contain
and to restrict any chemical, climatic, biological, microbiological or
occasionally mechanical hazards that may cause or lead to product
deterioration, and to ensure product stability and safety
throughout the intended shelf life of the products.
EXAMPLES OF Packaging material manufacturers who want to

PRIMARY PACKAGING MATERIALS supply to API, Excipient, and Drug Product
manufacturers for the markets of USA and
Glass Ampoules, Tubular Vials, Aluminum Foil for Canada, have the option to prepare Drug Master
Strip Packaging and Blister Packaging, PVC Films
Files for their packaging materials and submit
for Blister Packaging, Unprinted & Printed
them directly to the regulatory authorities in their
Laminates, Plastic Granules for Blow, Fill & Seal
target markets.
(BFS / FFS) Packaging, HDPE Bottles and Drums,
PET Bottles, Absorbent Cotton Wads, Induction A US Type III or Canadian Type II Drug Master File
Seals, Collapsible Aluminum Tubes, Laminated
supports a pharmaceutical manufacturer’s
Tubes, Plastic Tubes, Pouches, Retort Pouches,
application for approval by authorizing the
Plastic Caps and Closures, Rubber Closures, HDPE
regulatory authority to review confidential,
and LDPE Liner Bags, Laminated Paper Bags,
Aluminum Bags and Canisters
detailed information about facilities, processes, or
articles used in the manufacture of packaging
materials for storing of the Drug Product, API or
The FDA (USA) and the TPD (Canada) require that Excipient.
all IND, NDA, ANDA, BLA, NDS, ABNDS applicants PharmAlliance assists clients in rectifying any
must include complete details about packaging deficiencies in manufacturing facilities and
materials that are pertinent to the safety, purity quality systems, data generation, document
and efficacy of their products. Similarly, most preparation and review. We guide clients
other regulatory agencies around the world throughout the submission (electronic or paper)
require such information about primary packaging and post-submission regulatory processes,
materials used for packaging of Drug Products, including responses to deficiency letters (if any)
APIs, and Excipients to be included in applications and resolving queries to the satisfaction of the
for drug product approvals or registrations. FDA and TPD.
BENEFITS:
 Due to the importance of Primary Packaging Materials in the holding, protection and
stability of Pharmaceuticals, APIs, and Excipients in international markets, most
manufacturers prefer to buy from holders of US Type III DMFs, or Canadian Type II DMFs.
Having a DMF for these regions gives you more market coverage and additional business.
 Filing these documents with the regulatory authorities of USA and Canada gives you an
added advantage for selling your packaging materials to pharmaceutical companies, as
well as API and Excipient manufacturers marketing their products in these countries.
SERVICES:
 Quality Audits and Rectification of Deficiencies in Manufacturing Facilities Operations,
 Complete guidance on FDA (USA) and TPD (Canada) cGMP Compliance
 Preparation of US Type III and Canadian Type II DMFs as per the relevant regulatory
guidelines and conversion to electronic format for electronic submissions
 Review of DMFs prepared by your staff before filing.
 Appointment of Regulatory Agent(s)
 Submission of US Type III and Canadian Type II DMF
 Liaison with FDA (USA), TPD (Canada) or Regulatory Agent(s)



Support Services for Preclinical, Clinical and
Bioequivalence Studies
Approval of any pharmaceutical product requires
intensive and reliable data which would demonstrate its
safety and efficacy.
Prior to approval being granted, the manufacturer must
conduct a whole array of studies, covering
Pharmacodynamics, Pharmacokinetics, Dose Ranging,
Safety and Efficacy, first in animals, and then in human
subjects and generate the necessary data, in order to
establish that the drug is suitable for use. The animal
phase of testing is referred to as “Preclinical” and the
human phase of testing is referred to as “Clinical”.
For New Molecular Entities (NMEs): PHASE I: These are Initial studies in healthy human
participants and/or patients to determine the
Preclinical Studies metabolism and pharmacologic actions of the NME
in humans, the side effects associated with
The NME must be tested on animals for acute increasing doses, and to gain early evidence of
and chronic toxicity. Multiple species are used to effectiveness.
gather basic information about the safety and
efficacy of the NME. These studies must provide PHASE I/II (Device – Pilot): Some trials combine
detailed information on dosing and toxicity Phase I and Phase II, and test both efficacy and
levels. After preclinical testing, researchers toxicity (safety, dosage levels, and response to
review their findings and decide whether the new treatment).
drug should be tested on humans.
PHASE II: These are controlled clinical studies
Clinical Studies conducted to evaluate the effectiveness of the
agent for a particular indication or indications in
Clinical studies in human subjects are carried out patients with the disease or condition under study
in 4 phases (Phase 0, Phase I, Phase II, and and to determine the common short-term side
Phase III). Furthermore, products must also be effects and risks.
subjected to post-approval studies (Phase IV or
Pharmacovigilance Studies) to find out the PHASE II/III: Some trials combine Phase II and
incidence of adverse events related to the use of Phase III, and test for both efficacy and overall
benefit-risk relationship. The new treatment is
the drug in actual patients over a period of time.
compared to a standard treatment regimen.
PHASE 0: These are exploratory investigational
new drug studies conducted in a small number of PHASE III (Device – Pivotal): These are expanded
human volunteers, and also known as controlled and uncontrolled field trials after
“microdosing” studies. Exploratory trials are preliminary evidence suggesting effectiveness of
conducted to establish whether the NME behaves the NME or a device has been obtained. They are
in humans as was expected from preclinical animal intended to gather additional information to
studies and to gather preliminary data on evaluate the overall benefit-risk relationship and
pharmacodynamics or pharmacokinetics, to select provide an adequate basis for physician labeling.
promising lead candidates, or to explore These studies compare the NME or a device
biodistribution characteristics. against commonly used agents / test articles.
PHASE IV (Pharmacovigilance): These are post- Bioequivalence studies are carried out on human
marketing studies conducted to gather additional volunteers by comparing the bioavailability of the
information including the NME’s risks, benefits, generic drug product with the original innovator
comparative effectiveness, and optimal use. These (brand name) drug product which is designated as
studies are designed to monitor the effectiveness the Reference Listed Drug (RLD).
of the NME in the general population and to collect
information about any adverse effects associated Outsourcing of Studies:
with widespread use of the NME.
Most manufacturers prefer to have preclinical,
For Generic Drug Products: clinical and bioequivalence studies conducted by
Contract Research Organizations (CROs) that
Generic drug applications are termed
specialize in carrying out such studies.
"abbreviated" or “abridged” because they are
generally not required to include preclinical
PharmAlliance facilitates and provides support
(animal) and clinical (human) data to establish
services for studies across the entire pre-clinical
safety and effectiveness. Instead, generic
and clinical research spectrum as well as
applicants must scientifically demonstrate that
bioequivalence studies for worldwide regulatory
their product is bioequivalent (i.e., performs in
submissions.
the same manner as the innovator drug).
SERVICES:
 Assistance in identification of the right Preclinical, Clinical and Bioequivalence studies
needed for regulatory submissions
 Assistance in selection of Contract Research Organizations (CROs) best suited to specific

requirements, from a number of reputed CROs in the USA, Canada, Europe (including
Eastern Europe), and India that have comprehensive resources, expertise, and experience
 Audits of CROs for GLP and GCP compliance and expert guidance for negotiations with
CROs on behalf of clients for outsourcing studies
 Discussion of the acceptability of the proposed studies with regulatory authorities and
reviewing and finalizing the Study Protocols and associated documentation, such as
Volunteer Consent Forms, Case Report Forms, Investigator Manuals, etc., before
outsourcing the studies
 Monitoring study progress, reviewing interim study reports, and providing inputs for any
corrective actions that may be required relating to the conduct of the studies, once the
studies have been contracted
 Reviewing Study Report(s) to ensure that they meet the required submission standards,
and working jointly with CROs on behalf of clients to correct deficiencies, if any, upon
completion of studies



Reference Listed Drugs (RLDs)
A Reference Listed Drug (RLD) means the listed drug

identified by FDA (USA) as the drug product upon which
an applicant relies in seeking approval of its ANDA.
FDA has identified in the Prescription Drug Product and

OTC Drug Product Lists those Reference Listed Drugs to
which the in vivo bioequivalence (reference standard)
and, in some instances, the in vitro bioequivalence of the
applicant's product is compared. These lists are
commonly referred to as the “FDA Orange Book”.
A drug company seeking approval to market We can arrange to make available the
a generic equivalent must refer to the RLD in required quantities of Brand Name or
its ANDA. Innovator Drug products, listed as RLDs in
the FDA Orange Book, which are required
By designating a single RLD as the standard to as reference products to generate the
which all generic versions must be shown to pharmaceutical equivalence and
be bioequivalent, the FDA intends to avoid bioequivalence data for submission
possible significant variations among generic in ANDAs.
drugs and brand counterparts.
These RLDs can be supplied with proper
PharmAlliance provides clients with documentation establishing their pedigree.
comprehensive advice about selection of the
appropriate reference drugs against which You can contact us directly for all your needs
generic drug products can be compared, in of Reference Listed Drugs for your product
order to facilitate development and approval development projects or for your generic drug
of generic drug products. approval applications.



Approvals for Medical Devices
A medical device is an instrument, apparatus, implant, in
vitro reagent, or similar or related article that is used to
diagnose, prevent, or treat disease or other conditions, and
does not achieve its purposes through chemical action within
or on the body (which would make it a drug). Instead of
pharmacological, metabolic or immunological means, medical
devices act by physical, mechanical, thermal or other means.
Medical devices vary greatly in complexity and PharmAlliance provides critical inputs for
application. Examples range from simple devices appropriate regulatory classification of your
such as tongue depressors, medical medical devices in your target markets, based
thermometers, disposable gloves, bandages, on device description and specifications,
medical tapes, and braces to advanced devices intended clinical application(s), and labelling
such as implants, prostheses, pacemakers, claims.
stents, or non-computerized or computerized
equipment and systems which assist in medical Compliance and Submissions: We provide
diagnosis and testing. The design of medical support with rectification of deficiencies in
devices constitutes a major segment of the field your manufacturing facilities and quality
of biomedical engineering. management system documentation, review
your internal standard operating procedures
All countries comprising the “regulated” for quality control and quality assurance,
markets, as well as countries in the rest of the inspections, validation, qualification
world have established elaborate regulations (IQ, OQ, PQ), quality investigations, root-cause
governing the marketing approval of medical analyses, risk management, and CAPA planning.
devices. Regulations and requirements vary by
country, level of risk, specific product claims and Depending upon the classification of your
intended use. The regulation of medical devices medical device and your current stage of
covers the entire product lifecycle, from development, there are a variety of submissions
conception to post-market surveillance. that may be required by medical device
regulatory agencies in the USA, Canada, Europe,
Steering through the complex pathway from and around the world.
design to commercialization for a new medical
device or an in-vitro diagnostic device (IVD) can PharmAlliance can assist clients with clinical
be challenging. reviews, verification and validation test
summaries, clinical study design, pre-submission
PharmAlliance assists clients to gain in-depth meeting preparation, compilations and
understanding of the applicable requirements, submission of device regulatory dossiers. We will
even beyond what is available in published effectively address regulatory concerns and
regulations and guidance documents. minimize additional questions, respond to, and
interact with regulatory authorities worldwide.
Regulatory Strategy: We work closely with
We can assist clients through the entire
clients to generate cost-effective and realistic
development and submission process, or provide
regulatory and testing strategies to expedite
technical or regulatory support as needed, and
the entry of your devices into your selected
serve as your liaison from start to finish.
target markets.
BENEFITS:
 Getting approvals for your medical devices in the USA, Canada, Europe and other
regulated markets can put your company on the world map of the healthcare industry,
enhance your prestige and reputation, and give you an edge over competitors in any part
of the world.
 You will find it easier to gain market entry into many other countries that insist on
allowing only imports of devices that have been previously approved in these markets.
SERVICES:
 Manufacturing Facility and Quality Management System Audits, and comprehensive
advice in rectification of deficiencies in Manufacturing Facilities, Operations, and
Quality Management Systems
 General pre-submission assistance for European CE marking, US FDA’s 510 (K) or PMA,
or for device approvals / licenses in other countries by reviewing your product,
determining its device classification and route to conformance
 Complete and comprehensive support for the preparation of clinical reviews, verification
and validation test summaries, clinical study design, pre-submission meeting preparation,
response to and interaction with CDRH (US FDA), BMD (TPD Canada), European Competent
Authorities and Notified Bodies, as well as Regulatory Authorities in the rest of the world.
 Advice on labels, checking compliance and claims, and instructions for use
 Appointment of Regulatory Agent(s) in the USA, Authorized Representative(s) and Notified

Bodies in Europe
 Compilation of 510(k) or PMA submissions for FDA (USA), CE Technical Files / Design
Dossiers for European Notified Bodies, relevant Medical Device Dossiers for other
regulated markets and countries in the rest of the world
 Submission through US FDA’s 510(k) or PMA processes, CE mark process in Europe and
other regulatory approval pathways in the rest of the world, in paper or electronic format
 Liaison with FDA (USA), TPD (Canada) / Regulatory Agent(s) / European Authorized
Representative(s), Competent Authorities, Notified Bodies, and, and other worldwide
Regulatory Authorities
 Pre-inspection Audits of Facilities and Quality Management Systems



Electronic Regulatory Submissions
While many of the developed and developing
nations still support paper submissions as
opposed to electronic submissions until they
are equipped to fully accommodate
electronic submissions, the days of paper-
based submissions are now past.
A regulatory dossier in electronic format is
now essential in the global marketplace.
The electronic Common Technical Document Current Overview of e-Submissions Status at
(eCTD) is now entrenched as the global standard Regulatory Authorities around the World:
for regulatory submissions. The world’s leading
Regulatory Status of Status of Requirement
regulatory agencies have declared eCTD as the Authority eCTD NeeS for Paper
preferred format, and many have taken it a step
FDA Accepted; Not None
further, making it an outright mandatory (USA) Mandate Accepted
requirement. A majority of regional authorities Approved
Health e-CTD Format Not Co-
continue to provide updated guidance and Canada Recommended Accepted Submissions
validation criteria, making it critically important and Hybrid
that you stay informed and up-to-date. Submissions
no longer
Accepted;
Many global regulatory authorities, while “Print on
transitioning to the eCTD standard, also prefer Demand”
may be
to accept submissions in the Non-eCTD invoked for
electronic Submission (NeeS) format, instead of Modules
paper submissions. 3 to 5
EMA Mandatory as of No longer None
(Europe) July 2010 Accepted
Legislative actions by the world’s leading Various EEA Preferred by Accepted as Some
regulatory agencies, and advances in technology Authorities most Health per the Authorities
are convincing organizations to switch from Authorities discretion of still accept
Mandatory from individual full Paper
paper to eCTD format. Whatever the reason, January 2016 Authorities Submissions
many companies are now switching to electronic Swissmedic Mandatory as of Not None, as of
January 2010 Accepted January
submissions, or considering outsourcing to 2010, except
support in-house resources. for Signature
Documents
The FDA (USA) has already started the TGA Not Currently Accepted Paper Dossier
(Australia) Accepted may still be
countdown and established cut-off dates after Required
which paper submissions will no longer be MCC Accepted (Pilot) Not Paper Copy
accepted, and every submission filing has to be (South Accepted of Distinct
Africa) Documents of
made only in the electronic format. Module 1
Required
On May 15, 2015, FDA published its final “Guidance on PMDA Accepted Not Paper Dossier
Providing Regulatory Submissions in Electronic Format (Japan) Accepted no longer
– Certain Human Pharmaceutical Product Applications required with
eCTD
and Related Submissions Using the eCTD
ASEAN No Published Accepted Required
Specifications.” Plan by some
Authorities
Submission types NDA, ANDA, BLA and Master Files
Gulf Accepted; Accepted Paper Copy
must be submitted in eCTD format beginning May 15, Cooperation Preferred as of of Module 1
2017. IND submissions must be submitted in eCTD Council January 2014 information
format beginning May 15, 2018. required
PharmAlliance provides clients with complete We collaborate with e-publishing experts to

and comprehensive guidance throughout the manage all the technical information and
entire process in order to accelerate the e-submission requirements as per ICH and
transition to e-submissions and to enhance global regulatory agency eCTD or NeeS
client capabilities by supporting the complete specifications, which will result in high-quality,
e-submission process. validated and approvable electronic
submissions for your company.
BENEFITS:
 Moving from a paper-based format to an electronic system improves timeliness and
accuracy of submissions, facilitates finding information and navigation within documents
 Facilitates Submission Life Cycle Management – easy access to applications in terms of
making changes and keeping track of changes
 Uploads instantly and can be available to the reviewers within minutes
 Saves time and resources in printing, shipment and storage of paper submissions
SERVICES:
 e-Submission Strategy Development
 Conversion of Non-CTD to CTD Format as per ICH specifications
 Conversion of paper CTD to ICH compliant e-CTD for FDA (USA), TPD (Canada) EMA, EDQM
(Europe) and other global regulatory agencies
 Conversion of Paper CTD to NeeS Format with hyperlinks for global regulatory agencies
 Document-level authoring and publishing, bookmarking and hyperlinking for eCTD, SPL
and NeeS electronic submissions in country-specific formats which would be acceptable to
their respective regulatory authorities
 e-Submission Validation
 Submission Life Cycle Management
 Creation of US FDA Electronic Submission Gateway (ESG) WebTrader Accounts on behalf of

clients for all of their electronic submission requirements to FDA (USA) and TPD (Canada)*
*We have our own US FDA ESG WebTrader Account, with letters of non-repudiation for electronic signatures
in place with US FDA ESG. We can very easily create additional WebTrader Accounts on behalf of our clients
with the US FDA ESG for all of their electronic submission requirements.



Submissions to the US FDA’s
Electronic Drug Registration and Listing System
(eDRLS)
”Section 510 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) requires firms that
manufacture, prepare, propagate, compound, or process drugs in the U.S. or that are offered for
import into the U.S. to register with the FDA. These domestic and foreign firms must at the time of
registration, list all drugs manufactured, prepared, propagated, compounded, or processed for
commercial distribution in the U.S. Additionally, foreign establishments must identify a U.S. agent
and importers at the time of their registration.
Registration information must be renewed annually. The Food and Drug Administration Safety and
Innovation Act (FDASIA), signed into law on July 9, 2012, now requires drug firms to submit annual
establishment registrations in the period from October 1st to December 31st of each calendar
year. In addition, we remind you that at the time of annual registration, firms must list any drugs
not previously listed. The FDA no longer accepts drug establishment registration and drug listing
information in paper format unless a waiver is granted.”
The US FDA has discontinued accepting but they can pose an equal amount of difficulty
Establishment Registration and Drug Listing for your regulatory team if the technical
Information submissions in paper-based format, specifications and data requirements are not
i.e., in Form FDA 2656 (Registration of Drug fully understood.
Establishment / Labeler Code Assignment),
Form FDA 2657 (Drug Product Listing), and All electronic submissions require at least a
Form FDA 2658 (Registered Establishments’ working knowledge of Extensible Markup
Report of Private Label Distributors). Language (XML) structure and a thorough
understanding of FDA expectations related to
Submissions to the eDRLS, which include Drug electronic submissions, without which there is a
Establishment Registration Requests, NDC high probability of facing technical issues and
Labeler Code Requests, and Drug Product submission failures, resulting in spending a
Listing (NDC Number) Submissions in the considerably higher amount of time, effort and
Structured Product Labeling (SPL) file format, resources on the data generation and
are a small component of full eCTD submissions, submission process.
PharmAlliance offers start-to-finish expert checks prior to FDA submission. Our team can
outsourcing services for a variety of eDRLS identify, interpret and correct critical errors to
submissions via the US FDA Electronic prevent rejection and the need for multiple
Submissions Gateway (ESG). Our eCTD submissions.
publishing team is completely familiar with XML
and SPL requirements which are mandated by If you have issues with any eDRLS submission
the US FDA eDRLS. that has been rejected due to technical reasons,
we can analyze the error reports and correspond
We can create your eDRLS submissions from with the FDA, correct errors, and upload your
content that you supply and run validation submissions on your behalf through the ESG.
SERVICES:
 Assistance in completing all the information required to obtain a DUNS Number which is
essential in order to file eDRLS submissions for Establishment Listing, NDC Labeler Code,
and Drug Product Listings (Product NDC Numbers)
 Ensuring that the relevant details required for Establishment Listing, NDC Labeler Code and
Drug Product Listings are as per FDA Office of Compliance (OC) requirements
 Creation of electronic flies on the XML backbone for submitting Drug Establishment
Registration Requests, NDC Labeler Code Requests, and Structured Product Labeling (SPL)
for Drug Product Listing (Product NDC Number Submissions) to FDA through the Electronic
Submissions Gateway (ESG) using defined code sets and codes
 Creation of FDA Electronic Submission Gateway (ESG) WebTrader accounts on behalf of

clients for all EDRLS submissions*
*We have our own FDA ESG WebTrader Account, with letters of non-repudiation for electronic signatures in
place with FDA ESG. We can very easily create additional WebTrader Accounts on behalf of our clients with
the US FDA ESG for all of their electronic submission requirements.



Product Labeling
The safe use of all
drug products
depends on users
reading the labeling
and packaging
carefully and
accurately and being
able to assimilate and
act on the information
presented.
The primary purpose of drug product labeling the necessary information. This is a document
and packaging is the clear unambiguous provided along with a drug product, which gives
identification of the product and the conditions additional and complete information about
for its safe use. that drug as mandated by regulation.
All countries in regulated markets, especially the In the United States, package inserts (or
USA and EEA, have established detailed and outserts) are formally known as Prescribing
elaborate regulations governing the labelling of Information and in Europe, as Patient
drug products, and have defined structured Information Leaflets for human medicines
labelling specifications, for all drug products. or Package Leaflets for veterinary medicines
The primary reason for creating a structured PharmAlliance can review your product labeling
labeling specification is to ensure a uniform content, including label claims, for compliance
approach to developing labeling content. with US, Canadian, European, or other country-
specific guidelines, and provide complete inputs
Through the use of a standard, structured
to ensure that it meets specific regulatory
format, measurable improvements can be
requirements in any of your target markets.
achieved throughout the creation, review,
approval and overall management and We specialize in reviewing product
distribution of labeling content by both industry characteristics, and writing content for
and health regulatory authorities. Structured Product Labeling (SPL) submissions
The U.S. Federal Food, Drug and Cosmetic Act for the USA and Summary of Product
(FFDCA) defines 'labeling' as all labels and other Characteristics (SPC) submissions for Europe.
written, printed, or graphic matter upon any
We can design distinctive and compliant labels
article or any of its containers or wrappers, or
for your product containers and packages, along
accompanying such article. The term
with accompanying package inserts which fully
'accompanying' is interpreted liberally to mean
meet all relevant regulatory requirements. It is
more than physical association with the product.
not only important that labeling looks great, but
It extends to posters, tags, pamphlets, circulars,
also that the content complies with all the
booklets, brochures, instructions, websites, etc.
regulatory requirements of your target markets.
Product labeling must contain all elements
required by all applicable labeling regulations of PharmAlliance’s expertise will ensure that all of
the target countries in which the products are to your labeling materials meet regulatory and
be marketed. All drug products must include a marketing expectations without the risk of your
package insert if the label does not contain all products being found to be misbranded.

SERVICES:
 Label designing / Labeling artwork / Review of Clients’ proposed labeling: Ensuring that
the labeling meets relevant regulatory requirements so that the product is not at the risk
of being misbranded
 SPL and SPC writing and reformatting: Ensuring that all the information is given in a
reader-friendly way using everyday language, in QRD format
 Assistance in writing and reformatting Package Inserts: Prescribing Information (PI) and
Patient Information Leaflets (PIL) to ensure compliance with the relevant regulatory
requirements
 Conversion of labeling information for Prescribing Information (given either in MS Word

or PDF) into the SPL standard format for eDRLS submissions, as mandated by FDA (USA)


Training and Education
“Education is not the learning of

facts, but the training of the mind
to think.”
- Albert Einstein
PharmAlliance specializes in developing and Training Method:

conducting customized training programs,
workshops, and seminars for clients, which are Our training modules can be customized
unique to their specific needs. These programs according to the training needs of the client.
could cover any area of Operations, Regulatory Modules are designed to impart training which
Affairs and Compliance Management. is client-specific and relevant to the client’s
operating environment, taking into account
specific products, technology, processes, testing
Training can be conducted in-house for all levels
procedures, existing facilities and systems that
of management and operations personnel who
form an integral part of the operations.
are responsible for regulatory affairs, product
development, manufacturing operations and Modules are designed for groups of 10 to 25
in-process controls, quality control, quality participants, to facilitate participation and
assurance, and preclinical or clinical testing interaction among the group and with the
and research. resource person(s).
Areas of Customized Training:

 Regulations, Regulatory Procedures, and Strategic Planning for Regulatory Affairs:
FDA (USA), TPD (Canada), European Union, TGA (Australia), MEDSAFE (New Zealand),
ANVISA (Brazil), MCC (South Africa), WHO (Geneva)
 Regulatory and Development Strategies for Generics
 Compliance Management for International Markets
 Manufacturing and Control Operations
 Validation
 Bioequivalence Studies for Regulatory Submissions
 Clinical Pharmacokinetics and Protocol Design for Regulatory Submissions
 Pre-Clinical and Clinical Research and Clinical Trials Management

TRAINING MODULES:
 Regulations, Regulatory Procedures, and Strategic Planning for Regulatory Affairs:
FDA (USA), TPD (Canada), European Union, TGA (Australia), MEDSAFE (New Zealand),
ANVISA (Brazil), MCC (South Africa), WHO (Geneva)
• Legislation and Regulations
• Regulatory Approval / Registration Procedures
• Strategic Planning for Regulatory Affairs
• Regulatory Documentation: CTD, and other Regulatory Submissions
• Electronic Submissions (eCTD and NeeS)
• The US FDA Electronic Drug Registration and Listing System (eDRLS)
 Compliance Management for International Markets

• Good Manufacturing Practices (GMP)
• Good Laboratory Practices (GLP)
• Good Clinical Practices (GCP)
• Internal Audits, Contract Audits, Vendor Audits
• Standard Operating Procedures (SOPs)
• Records and Reports
 Manufacturing and Control Operations

• Quality, Quality Control, and Quality Assurance
• Documentation for Quality Assurance
• Design and Construction of Manufacturing Facilities
• Sanitation and Hygiene in Manufacturing Facilities
• Personnel Hygiene, Changing and Gowning Procedures
• Equipment Design, Selection, and Placement
• Maintenance and Cleaning
• Calibration of Process and Analytical Equipment
• Materials Management
• Production and In-process Controls
• Line Clearance Procedures
• Packaging, Labeling, Storage and Distribution Operations
• Complaints and Recalls of APIs, Drug Products and Devices
• Rejection and Re-use of Materials
• Stability Study Programs for APIs and Drug Products
 Validation
• Validation Policy and Validation Master Plan
• Validation of Water Systems
• Validation of HVAC Systems
• Cleaning Validation
• Equipment and Process Validation
• Validation of Testing/Analytical Methods
• Validation Documentation
• Change Control
 Bioequivalence Studies for Regulatory Submissions
 Clinical Pharmacokinetics and Protocol Design for Regulatory Submissions
 Pre-Clinical and Clinical Research and Clinical Trials Management
Business Development Consulting Services
What PharmAlliance can offer you...

 An extensive information database, and worldwide contacts
 Insight into worldwide market opportunities
 International Patent Screening
 Product / Market Selection
 Regulatory Strategy Development
 Strategic Planning for International Market Development
 Identifying potential Sponsors, Customers and Distributors
 Market Penetration into the profitable, multi-billion dollar North American
and European markets, as well as the rapidly growing markets of
Asia and Latin America.
 Inbound or outbound Contract Manufacturing, Contract Testing, Product
Development, or Contract Preclinical and Clinical Research arrangements
 Product In-Licensing and Out-Licensing arrangements
PharmAlliance can provide insight into If you already have, or are looking to create
worldwide market opportunities for your facilities and infrastructure for manufacturing,
organization. Our services range from assisting repackaging, warehousing and distribution,
you to identify market opportunities for existing analytical testing, product development,
or new products and services, to providing you preclinical or clinical research, we can help you
with detailed market evaluations and helping to prepare your facilities and quality systems to
you to establish presence for specific products meet international regulatory compliance
and services in markets of your interest. standards, and assist you in setting up of in-
licensing or contract manufacturing, contract
If you already have product approvals or testing, product development or contract
registrations and a presence in any of the research arrangements for your facilities
regulated or other world markets, but are still and services.
looking to expand your market coverage, we can
If you are looking to benefit from lower costs of
offer you the opportunity of gaining additional
manufacturing, repackaging, analytical testing,
sales revenues through private label distribution
product development, or preclinical or clinical
arrangements, or product out-licensing
research, we can help in outsourcing your
arrangements without compromising on your
activities by locating contract manufacturing,
existing market share.
contract testing, product development or
contract research facilities in the rapidly
If you are planning to obtain product approvals
developing Asian or other regions, conducting
or registrations (innovator or generic) in your
cGXP audits of these facilities, and monitoring
own name in any of the regulated and / or other
them periodically for regulatory compliance on
world markets and looking to expand your
your behalf.
global market reach, we offer a complete
turnkey infrastructure to assist you in product / If you are a manufacturer of APIs, Excipients, or
market selection, preparing your facilities and Packaging Materials that are the subject of
quality systems to comply with international Drug Master Files, or Certificates of Suitability in
regulatory expectations, provide comprehensive regulated markets such as the USA, Canada, or
advice for product development, regulatory Europe, we can help you to locate dosage form
strategy, regulatory filings, to win approvals or manufacturers who would be willing to apply for
registrations for your products. Through our an approval or authorization for a dosage form
worldwide contacts, we can then assist you in containing your API, Excipient, or Packaging
identifying sales and distribution arrangements Material. Such dosage form manufacturers are
in the target markets. generally referred to as “sponsors".
If you are looking to enter into regulated or We can ensure that sponsors provide
other worldwide markets by building long-term information about brand names, product
relationships with overseas companies for your licenses, and commercialization dates, which
pipeline or existing products, whether innovator are critical for obtaining Certificates of
or generic, we can help you to locate partners Suitability in Europe.
worldwide for out-licensing, or, who would be Either way, we will bring to your organization
willing to provide funding for development and our impressive information and knowledge base,
regulatory approvals of products of their our worldwide contacts, our strategic planning
interest, in exchange for exclusive ownership and project management skills and systems to
rights to your products in the specified markets track every detail, without losing sight of project
or countries. objectives.


Business Development Consulting Services...

Contract Manufacturing, Testing, Product Development,
Preclinical and Clinical Research Arrangements
Benefit from the state-of-the-art technical infrastructure and
highly skilled human resources in India, China, and other emerging markets...
Companies outsource their manufacturing, We can conduct due diligence, as well as

testing, product development, and preclinical or cGXP (GMP, GLP, GCP) audits of such facilities to
clinical research activities to other companies assess potential collaborators, and also
because of significant cost benefits. Outsourcing periodically monitor them for regulatory
can save money, time and effort on investing in compliance on behalf of our clients.
facilities, resources and equipment, and also on For clients who wish to develop and subsequently
hiring and training specialized staff. Outsourcing manufacture specific products at a contract
to countries that can manufacture products, or manufacturing facility, we provide complete
provide specific services at significantly lower inputs for generation of the relevant regulatory
costs can add even more cost benefits. data for preparation of all types of regulatory
Many firms in India, China and other developing submissions in the CTD, eCTD, or alternative
countries have state-of-the-art facilities and formats and filing them with regulatory agencies
human resources with the required qualifications, in the USA, EU, Canada, Australia, New Zealand,
capabilities and skills to conduct all of these Latin America, South Africa, the WHO (Geneva),
activities. These firms have been inspected and as well as in other countries.
accredited by worldwide regulatory authorities, We ensure that contractors’ manufacturing,
and already have a significant presence in the testing, product development, preclinical or
markets of the USA, Canada, Europe, Australia, clinical research facilities are prepared to face
South Africa, Asia, Latin America and Africa. customer audits as well as regulatory inspections,
There are many more firms in these countries and assist with inputs in rectifying deficiencies in
who have invested in facilities and human facilities, operations, quality systems, as well as in
resources development, and are looking to enter responding to deficiency letters, if any, until
into contract manufacturing, testing, product approval is achieved.
development, and clinical research arrangements With our contacts across a wide range of
with firms in worldwide markets. manufacturing, testing, and research
organizations in the field of finished dosage forms,
PharmAlliance can assist clients in locating
active pharmaceutical ingredients, excipients,
contract manufacturing, testing, product
medical devices, and packaging materials, we can
development, preclinical or clinical research
assist our clients in achieving optimal synergies in
facilities for outsourcing to these countries.
their manufacturing, testing and research goals.


Our Team
ASAF SHAMSI
B. Pharm. (University of Delhi), MBA (B K School of Business Management, Ahmedabad)
CEO, & Director, International Operations
 A pharmaceutical industry professional who has worked in senior-level positions for corporate
organizations, and as a consultant based in North America and India in close association with
clients in India, USA, Canada, Europe, China, Latin America, Africa etc., representing their
interests in worldwide markets, and regulatory agencies in North America, Europe, and other
countries
 Over 30 years of experience in regulatory affairs, cGXP auditing, quality systems, compliance
management, conceptualization, design and set-up of state-of-the-art manufacturing, testing
and R&D facilities, strategic planning, business development, and international trade in the
pharmaceutical and related industries in regulated and other emerging markets worldwide
 Knowledge of current industry regulations, as well as future policy shifts in several countries,
insight into how regulatory agencies think, and what data they will need to approve specific
products
 Personal contacts in international markets, and extensive experience in interacting with
regulatory agencies in the USA, Canada, Europe, Australia, China, Latin America and Africa as
well as the WHO (Geneva)
 Strong project management and interpersonal skills
 Eligible to live, work, and conduct business in India, Canada, USA, and can travel freely
(without a visa) and conduct business anywhere in the EU, some non-EU countries in Europe,
Australia & New Zealand, some countries in Latin America, the Far East, and Africa
M. R. ADWALPALKAR
M. Sc., Chemistry (University of Bombay)
Director, Technical Services
 Over 50 years of industrial experience including top-level positions in pharmaceutical project

implementation, manufacturing, quality assurance, and regulatory affairs in several
organizations (Hindustan Antibiotics Ltd., Goa Antibiotics Ltd., Torrent Pharmaceuticals Ltd.),
and as a consultant to the Indian pharmaceutical industry
 Extensive experience and strong skills in regulatory documentation, SOPs, validation
procedures, quality assurance and manufacturing controls
 Expert in implementation of quality systems and international cGMP norms as required by
FDA (USA), EDQM, EMA, WHO and ISO-9002
A. T. VIVEK
M.Sc., Biotechnology (Utkal University),
M. Tech., Medical Biotechnology (Indian Institute of Technology, Madras)
Manager – Projects
Vivek has specialized in various fields of Medical Biotechnology, especially domains like Engineering
Aspects of Physiology, Drug Design, Medicinal Chemistry, and Regenerative Medicine. He is also
experienced in working with techniques like Lymphocyte Culture, Immunohistochemistry,
Chromatography and various Molecular Biology techniques pertaining to DNA, RNA and Plasmids.
His scientific research work included interaction with different groups including exchange of resources
and possible solutions in addressing research challenges that got him associated with laboratories of
other fields of Medical Biotechnology, enhancing his abilities to work in a team and contribute to the
success of the projects undertaken.
His brilliant academic background also qualified him for a number of national level scholarships,
including the Centre for Scientific and Industrial research (CSIR) and one funded by the Department
of Biotechnology, Government of India.
Vivek’s qualifications, eye for detail, combined with his experience since March 2012, working on
diverse projects at PharmAlliance, gives him a special edge as an expert auditor, especially in
evaluating the data integrity of scientific, technical and regulatory documentation.
Vivek also contributes very substantially in the conceptualization and design of manufacturing, testing
and research facilities, and development and implementation of quality systems that not only meet,
but exceed the most stringent international regulatory expectations.
Panel of Experts
DR. SHIV CHOPRA

B.V. Sc. (Punjab) M. Sc., Ph. D., Microbiology (McGill University, Montreal),
Post-Doctoral Fellow, World Health Organization (WHO)
Dr. Shiv Chopra is a scientist who has had a long and illustrious career with numerous eminent posts
in India, England and Canada. He spent a majority of his working life (over 35 years) as a health
regulator at Health Canada, in the Bureau of Human Prescription Drugs and the Bureau of Veterinary
Drugs.
He is the recipient of numerous academic awards, including a Fellowship of the World Health
Organization in the area of Biologics and Vaccines, and has many scientific publications in his name.
Some of the positions he has held include:
• Biologics Production and Quality Control Research Department, Punjab Veterinary College
(Vaccine Program)
• Director of R&D (Biologics), Miles Laboratories, Stoke Podges, England. UK
• Senior Scientific Advisor, Bureau of Human Prescription Drugs,
Health Protection Branch, Health Canada
• Management Consultant to the Director General, Health Protection Branch,

Health Canada
• Acting Chief, Human Safety Division, Bureau of Veterinary Drugs, Health Canada
Apart from his work in science, Dr. Chopra is a highly acclaimed leader and spokesperson on a variety
of public health, social and cultural issues in Canada, and around the world.
He is the author of a number of publications on society, theology and religion, including poems, essays,
and books, and has received many public service and community service awards for his contributions
to society.
DR. YAQOOB ALI

B. Tech., Chemical Engineering (Harcourt Butler Technological Institute, Kanpur)
M. Tech., Chemical Engineering (Indian Institute of Technology, Kanpur)
Ph. D., Chemical Engineering (Indian Institute of Technology, Kanpur)
Dr. Yaqoob Ali is considered to be an international expert in process design and process improvement.
He has held many senior-level positions in reputed pharmaceutical companies, both Indian, as well as
multinational, and has over 27 years of experience in the pharmaceutical industry.
Some of the positions he has held in highly reputed companies are Chief Operating Officer (COO),
Manufacturing Director, and Senior Vice President – Technical.
Dr. Ali has an impressive list of research publications to his credit. His research article on sensor
network design has been adjudged among the top 200 articles published in chemical engineering
journals, pertaining to process systems engineering in the last 100 years. He has also been a frequent
invitee to deliver lectures and talks on various subjects pertaining to the pharmaceutical industry.
With his solid foundation in the knowledge of chemical processes, Dr. Ali has contributed very
substantially towards improving the efficiency and profitability of all the organizations he has been
associated with.
He has a thorough understanding of the present-day business environment pertaining to the

worldwide pharmaceutical industry and the current regulatory standards that the industry is expected
to comply with.
Dr. Ali is currently the Chief Executive Officer, Y-Chem Consulting, in Mumbai (Bombay), India and
provides key inputs and expert advice to many reputed companies in order to help them in achieving
worldwide standards of excellence and compliance.
DR. RAMESH K. GOYAL

B.Sc. (Hons), M.Sc. (Medical), Ph.D. (Pharmacology)
Dr. Ramesh K. Goyal is a distinguished and a widely acclaimed academician and research scientist, with
a passion for New Drug Discovery Research. He is currently Executive Director (Research & Strategies)
at V ClinBio Labs, Sri Ramachandra Medical Centre & Research Institute, SRU, Chennai, India.
He is the author of 15 books, 30 book chapters, and has over 260 full research papers, 300 abstracts
and 18 review articles published in reputed international and national journals to his credit. He is the
recipient of many national and international awards, honors and fellowships for outstanding
research in Pharmacology and has guided over 200 students at the post-graduate and Ph.D. level.
Dr. Goyal was also the Vice Chancellor of the prestigious Maharaja Sayajirao University
(M. S. University), Baroda, India, from 2008-2011.
The other eminent positions that he has held include:
 Distinguished Professor, Institute of Life Sciences,

Ahmedabad University, Ahmedabad, India
 Director (Pharmacology & Clinical Research),
SPP School of Pharmacy & Technology Management, NMIMS, Mumbai (Bombay), India.
 Professor and Head of the Department of Pharmacology,
L. M. College of Pharmacy, Ahmedabad, India, where he served for 35 years till May, 2008.
In addition, Dr. Goyal is extremely active in numerous professional, academic and industry associations
and societies. Some of his affiliations include:
 Visiting Scientist at the University of British Columbia, Vancouver, Canada,

Visiting Professor at the Institute of Cardiovascular Sciences, University of Manitoba,
Winnipeg, Canada, and a regular invitee to deliver Guest Lectures at many Universities and
Scientific Conferences worldwide.
 Fellow and Former President, Indian Pharmacological Society (Parent Body)
 Fellow of Institute of Chemists (India)
 Member, Executive Committee, All India Council for Technical Education (AICTE)
 Member of National Academy of Medical Sciences
 Fellow, International College of Nutrition
DR. C. J. SHISHOO
B. Sc., B. Pharm., M. S., (Pharmaceutical Chemistry), Ph.D.
Formerly Principal and Head of the Department of Pharmaceutical Chemistry, L. M. College of

Pharmacy, Ahmedabad, India, Dr. Shishoo has an impressive track record of research and guiding
institutions and industry.
During the course of his academic career Dr. Shishoo has been a research guide to numerous Ph.D.
students in Medicinal and Pharmaceutical Chemistry.
He has chaired scientific sessions in many international conferences, and is on the editorial and
advisory boards of national and international journals. Dr. Shishoo has more than 75 publications in
reputed International and National Journals, including 4 review articles.
He has patents on an antihyperlipaemic agent and its synthesis.
Dr. Shishoo currently holds key positions in several national and international institutions:
• Trustee, Consumer Education and Research Society (CERC)

• Advisor - Laboratory for testing of Drugs and Pharmaceuticals, CERC
• Chairman - Independent Ethical Committee for Clinical Trials
• Collaborations with National Institute of Health, USA (Anticancer Screening Program), and
Southern Research Center, Alabama, USA (testing of anti-tubercular compounds)
• UNDP travel grants for visiting several drug testing laboratories in UK, USA and Austria
DR. KISHOR S. JAIN

M. Pharm., Ph. D. (Pharmaceutical Chemistry), F.C.I.
Dr. Kishor S. Jain has over 30 years of a unique and varied blend of experience in both academia, as
well as industry. He is currently Principal at the Shri Fattechand Jain College of Pharmacy, Pune India.
His area of specialization is Synthetic Medicine, with a solid foundation in basic research (NDDR,
CADD & QSAR), as well as applied research (Process Development). Dr. Jain has successfully
developed processes for many drugs, intermediates and fine chemicals from laboratory to plant scale.
He has more than 100 research publications in reputed international journals, and is well-versed with
latest research and process techniques.
Dr. Jain’s experience includes distinguished and senior-level positions in both academia, as well as
pharmaceutical and API (Active Pharmaceutical Ingredient) manufacturing companies.
 Principal and Professor,
Shri Fattechand Jain College of Pharmacy, Pune India.
 Principal and Professor,
Sinhgad College of Pharmacy, Pune, India
 Director, Chemtek Laboratories, a Custom Synthesis CRO,
Pune, India
 Former In-Charge Dean: Faculty of Pharmacy,
Pune University, Pune, India
 Professor of Medicinal Chemistry,
Bharati Vidyapeeth’s Poona College of Pharmacy, Pune, India
 Vice President (R&D), Dishman Pharmaceuticals & Chemicals Ltd.,
Ahmedabad, India
In addition, Dr. Jain is extremely active in numerous professional, academic and industry associations
and societies. Some of his affiliations include:
 Member: American Chemical Society (ACS)

 Fellow Member : The Institute of Chemists, India (F.I.C.)
 Member : Academic Council, Pune University
 Member : Board of Studies – Pharmaceutical Chemistry, Pune University
 Life Member: The Indian Pharmaceutical Association (I.P.A)
 Life Member: The Indian Society of Technical Education (I.S.T.E.)
 Life Member: The Administrative Staff College of India (A.S.C.I.)
 Member of Advisory Board: South Asian Advisory Panel – Pharmacy,
Wolters Kluwer Health / Lippincott, Williams & Wilkins.
Unit 401, Ashirwad Complex

Opp. Sardar Patel Sewa Samaj Hall
Mithakhali, Ellis Bridge
Ahmedabad 380006, India
Tel: +91 (79) 2646-1411
e-mail: info@pharmalliance.com
Web: www.pharmalliance.com

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Where Expectations Meet Expertise

Where Expectations Meet Expertise

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PharmAlliance is a knowledge driven, Our client base comprises of a cross-section

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 Detailed User Requirement Specifications (URS)

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Country / Services Matrix

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Project cGXP cGXP Regulatory Preclinical, RLDs Business

* Using the CESG (Common / US FDA Electronic Submissions Gateway)

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Conceptualization and Design of Manufacturing,

The Need… …and Our Response

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WE OFFER INTEGRATED PROJECT SERVICES FOR:

 Active Pharmaceutical Ingredients (APIs)

 Pharmaceuticals and Biopharmaceuticals

 Excipients (Non-sterile, Sterile)

 Medical Devices and Disposables (Non-sterile, Sterile)

 R&D / Product Development and Testing Facilities:

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Quality Systems Development & Implementation

“The requirements of good manufacturing, laboratory and clinical

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PharmAlliance provides comprehensive advice on required to be included in regulatory submissions.

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 21 Code of Federal Regulations Parts 210 and 211:

 EudraLex Volume 4: Good manufacturing practice (GMP) Guidelines Parts I - III:

 World Health Organization:

 ICH Harmonised Tripartite Guideline Q7:

 International Pharmaceutical Excipients Council:

 21 Code of Federal Regulations Subchapter – H: Medical Devices, Part 820:

 European Union “Medical Device Directive”:

 21 Code of Federal Regulations: Part 58:

 ICH Harmonised Tripartite Guideline E6(R1): “Good Clinical Practice”

 ICH Harmonised Tripartite Guideline Q9: “Quality Risk Management”

 ICH Harmonised Tripartite Guideline Q10: “Pharmaceutical Quality System”

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 cGMP Audits and Rectification of Deficiencies in Manufacturing Facilities, Operations,

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Worldwide Regulatory Affairs Consulting Services…