Regulatory Documentation Portfolio:

Qualification Risk Assessment

All department SOPs & Formats
Research and Development
Product Development Lab
Technology Transfer Department
Analytical Department
Corporate Quality Assurance
Plant Quality Assurance
Quality Control
Microbiology Department
Production department
Engineering Department
Maintenance Department
Ware House Department
Raw Materials Ware House
Finished Goods Ware House
Distribution Finished Goods
Analytical Development Protocol Report
Lab Scale Batch Report
Pilot Scale Batch Report
Technology Transfer Dossier
Risk Base Approach
Protocol and Report
Scale up Batch Record
Protocol and Report
Exhibit Batch record
Protocol and Report
Process Validation
Protocol and Report
Process Equipment Cleaning Validation
Protocol and Report
Facility Cleaning Validation
Protocol and Report

Regulatory Services
Preparation of chemistry, manufacturing, and controls (CMC) documentation for drug
substances and finished formulations Preparation of Clinical and Non Clinical
(Overviews & Summaries), Study Reports, Protocols and others To Prepare, Compile, &
Submit DMFs & Dossiers (Investigational Medical Product Dossier (IMPD) /
Investigational new drug (IND) applications, NDAs and Generics for various
countries Preparation and Submission of Annual Reports, Variation Applications,
Renewal Application, Amendments and Supplements Briefing Documents Response to
queries from Regulatory Authorities Life Cycle Management

Development of patent non infringing / stable and bio-equivalent products.

At-a-glance: Pre-submission Service:

Regulatory Affairs support (CTAs, IMPDs, INDs, NDAs, MAA, global registration
submission)
CMC Authorship (CTAs, IMPDs, INDs, NDAs, MAA, global registration
submissions)
Regulatory Affairs and CMC strategic guidance
Publishing support all submission types and format, and reports
Regulatory Intelligence
DMFs
EDQM Certificate of Suitability applications
 Stability data assessments

At-a-glance: The Post-Submission Service:

Regulatory Affairs support across the lifecycle (variations, renewals, annual
reports)
CMC Authorship across the lifecycle (variations, renewals, annual reports)
Regulatory Affairs and CMC strategic guidance
Publishing support all submission types and format, and reports
Labeling
Regulatory Intelligence
Site rationalization regulatory support
Stability Data Assessments
CTD Conversions (content and format)
Clinical Trial support for Clinical Development, Bioavailability &
Bioequivalence studies activity

Countries we serve
Abbreviated New Drug Application (ANDA) - US
European Union Registration - EU
Agencia Nationale Vigilenca de Sanitaria (ANVISA) - Brazil
Medicines & Healthcare Products Regulatory Agency (MHRA) - UK
Therapeutic Goods Administration (TGA) - Australia
Medicines Control Council (MCC) - South Africa
Commonwealth of Independent States (CIS) Registration
Registration in all other Regions across the globe