REGULATORY AFFAIRS
- DMF ,Dossier (CTD & ACTD) & as per country specific guideline
- Preparation / Review /Submission
- Product registration: Dossier Submission to various regulatory agencies worldwide
- Handling query response and Gap analysis of existing Document
- Artwork & Labelling
- Ba/BE Studies and assistance for clinical data
- GMP /Site due Diligance for API sites , FP sites & Manufacturing sites
- Guidance & Assistance for submission of the site/plant registration document to MOH of different country
- Pre & Post plant audit and compliance assessment
- Development & Preparation of R & D documents
- Reference listed Drug (RLD) / Innovator product / Competitor
- Market information survey for new molecules