REGULATORY DOSSIER SERVICES

 

Foray Life Sciencience Ltd is a comprehensive consultancy service provider in the area of regulatory affairs offering dossier compilation and submission for product registration in various markets.

We can work with you for pre-authorization submission in designing a regulatory strategy and a programme that meets your needs and that of the regulatory authorities.

Once you have your authorization, we can assist you to ensure that your post-authorization requirements and responsibilities are met.

Our comprehensive services include:

• Quick dossier compilation and review

• Draft pre-formulation, BMR, MFR, process validation, method validation, dissolution and stability studies documents

• Clinical and non-clinical overviews

• Justification for fixed dose combination

• Prepare Summary of product (SmPC) and Pack Information Leaflet (PIL)

• Prepare label and carton contents

• Reply to MOH queries

• Product registration assistance

• Product development assistance

• Global Patent Information

• Literature for patented product

• Non-infringing process

 

Foray Life Science  strives to develop long-term relationships with clients, based on the highest levels of integrity, professionalism and trust. We are committed to doing business in an ethical and socially responsible manner.

Contact us at savuth@foraylifescience.com