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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
Where Expectations Meet Expertise
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
Where Expectations Meet Expertise
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)
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
Where Expectations Meet Expertise
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)
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
Where Expectations Meet Expertise
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)
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
Where Expectations Meet Expertise
RUSSIA CIS
4. AND Registration -
CIS Dossiers
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
Where Expectations Meet Expertise
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)
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
Where Expectations Meet Expertise
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
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
Where Expectations Meet Expertise
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)
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
Where Expectations Meet Expertise
A New Dimension to
Project Services…
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
Where Expectations Meet Expertise
API Intermediates
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.
Avoid an endless cycle of queries and replies at the cost of market opportunities...
Expertise… Experience… Excellence… PharmAlliance…
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
Where Expectations Meet Expertise
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.
Avoid an endless cycle of queries and replies at the cost of market opportunities...
Expertise… Experience… Excellence… PharmAlliance…
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
Where Expectations Meet Expertise
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
Where Expectations Meet Expertise
Avoid an endless cycle of queries and replies at the cost of market opportunities...
Expertise… Experience… Excellence… PharmAlliance…
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
Where Expectations Meet Expertise
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:
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
Where Expectations Meet Expertise
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.
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
Where Expectations Meet Expertise
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)
Avoid an endless cycle of queries and replies at the cost of market opportunities...
Expertise… Experience… Excellence… PharmAlliance…
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
Where Expectations Meet Expertise
BENEFITS:
Penetrating these high entry-barrier markets means lesser competition, better price
realizations, more sales revenues, and sustained long-term profits.
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.
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
Where Expectations Meet Expertise
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
Submission of DMFs / ASMFs (EDMFs) / APIMFs to the relevant authorities in CTD (paper),
eCTD or NeeS (electronic) formats
Sponsor Identification
Avoid an endless cycle of queries and replies at the cost of market opportunities...
Expertise… Experience… Excellence… PharmAlliance…
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
Where Expectations Meet Expertise
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.
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
Where Expectations Meet Expertise
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.
Growth in global market share, better price realizations, and sustained long-term profits
SERVICES:
cGMP Audits and Rectification of Deficiencies in Manufacturing Facilities, Operations,
Quality Systems and Documentation
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
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
Renewal of Certification
Avoid an endless cycle of queries and replies at the cost of market opportunities...
Expertise… Experience… Excellence… PharmAlliance…
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
Where Expectations Meet Expertise
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.
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
Where Expectations Meet Expertise
SERVICES:
cGMP Audits and Rectification of Deficiencies in Manufacturing Facilities, Operations,
Quality Systems and Documentation
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
Submission of US Type IV DMFs, Canadian Type III DMFs and Excipient Master Files
Sponsor Identification
Avoid an endless cycle of queries and replies at the cost of market opportunities...
Expertise… Experience… Excellence… PharmAlliance…
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
Where Expectations Meet Expertise
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.
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
Where Expectations Meet Expertise
SERVICES:
Quality Audits and Rectification of Deficiencies in Manufacturing Facilities Operations,
Quality Systems and Documentation
Preparation of US Type III and Canadian Type II DMFs as per the relevant regulatory
guidelines and conversion to electronic format for electronic submissions
Sponsor Identification
Avoid an endless cycle of queries and replies at the cost of market opportunities...
Expertise… Experience… Excellence… PharmAlliance…
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
Where Expectations Meet Expertise
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.
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
Where Expectations Meet Expertise
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
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
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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
Where Expectations Meet Expertise
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.
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Expertise… Experience… Excellence… PharmAlliance…
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
Where Expectations Meet Expertise
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.
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
Where Expectations Meet Expertise
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.
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 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
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
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Expertise… Experience… Excellence… PharmAlliance…
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
Where Expectations Meet Expertise
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
Where Expectations Meet Expertise
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 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
*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.
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Expertise… Experience… Excellence… PharmAlliance…
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
Where Expectations Meet Expertise
”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.
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
Where Expectations Meet Expertise
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
*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.
Avoid an endless cycle of queries and replies at the cost of market opportunities...
Expertise… Experience… Excellence… PharmAlliance…
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
Where Expectations Meet Expertise
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.
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
Where Expectations Meet Expertise
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
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Expertise… Experience… Excellence… PharmAlliance…
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
Where Expectations Meet Expertise
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
Where Expectations Meet Expertise
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
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
Where Expectations Meet Expertise
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
Where Expectations Meet Expertise
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.
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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
Where Expectations Meet Expertise
Avoid an endless cycle of queries and replies at the cost of market opportunities...
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
Where Expectations Meet Expertise
Our Team
ASAF SHAMSI
B. Pharm. (University of Delhi), MBA (B K School of Business Management, Ahmedabad)
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)
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
Where Expectations Meet Expertise
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.
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
Where Expectations Meet Expertise
Panel of Experts
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.
• 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
• 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.
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
Where Expectations Meet Expertise
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.
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.
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
Where Expectations Meet Expertise
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.
In addition, Dr. Goyal is extremely active in numerous professional, academic and industry associations
and societies. Some of his affiliations include:
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
Where Expectations Meet Expertise
DR. C. J. SHISHOO
B. Sc., B. Pharm., M. S., (Pharmaceutical Chemistry), Ph.D.
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.
Dr. Shishoo currently holds key positions in several national and international institutions:
• 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
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
Where Expectations Meet Expertise
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:
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
Where Expectations Meet Expertise
e-mail: info@pharmalliance.com
Web: www.pharmalliance.com