Our focus is to offer supportive services to Regulatory Departments of Pharmaceutical Companies in the field of Registering Pharmaceutical Dossier Writing. We are have been involved with all aspects of regulatory affairs, from supporting Clinical trials, bioequivalence reports, validation data, Expert reports, Data for Overview, PSUR through registration activities, compilation of Pharmaceutical dossier / application for registrations of medicines and E-Filings to post-marketing regulatory obligations for Pharma Industry. We also offer ‘Gap Analysis’ which is a meticulous review of the dossier ready for submission.
We have rich experience of providing services across therapeutic segments (including animal health and herbal products) and have registered more than
10000 products in over
100 countries for more than
1000 pharmaceutical companies.
We have excellent contacts all over India and therefore we also provide liaison services for those who wish to search for suppliers of raw materials, products and processes, as well as for those who wish to expand their global presence in a very telling manner. Business consultancy is provided on various aspects related to imports, exports, regulations, market conditions, competition, product viability, etc.
