We provide a full range of Food and Pharmaceutical Regulatory Affairs consulting services to the Pharmaceutical, Biotechnology and Healthcare Industries. Our expertise covers all stages of the product lifecycle and each service is delivered by a specialist in their field with the relevant knowledge and experience.


Our services include:

Preparation and filing of Registration dossiers for submission to various regulatory agencies all over the world (including eCTD, CTD format & ACTD Format).
Drug Master File (DMF) compilation for open and closed part.

Preclinical and clinical overviews writing through literature search / published studies / articles from journals from different sources.

Expert reports on Quality ,  Pre-clinical and Clinical

Orphan Drug Application Preparation and Submission.

Prepare summary of product characteristic (SmPC), Pack Insert, Product rationale.

Assistance in Response to queries for submission to the Regulatory Agencies.

Total development of product from lab scale to pilot plant scale to actual production scale for Drug Substance and Drug product.

Prepare summary of product characteristic (SmPC), Pack Insert, Product rationale.

Periodic Safety Update Report (PSUR) preparation.

Provide analytical support in analytical method development / validation, Routine analyses of products by HPLC/GC/MS etc.

Complete stability programme management service is provided as per ICH guidelines / special requirements in a cGMP and GLP compliant environment.

Monitoring and liaisoning with the CRO’s for Clinical and BE Studies.

Preparation of Site Master file

Compilation of dossier as per latest country specific guidelines

Asean Common Technical Dossier (ACTD)          Guidelines.
       South Africa (MCC-MRF-1) Guidelines.
       Brazil ANVISA Guidelines.
  

Asia
        Africa
        Central  America
        South  America
        North  America

Commonwealth of Independent States
       (CIS) Guidelines.
       South East / West Europe Guidelines.