Drug Regulatory Affairs
- Preparation of Drug Substance and Drug product registration dossier
- Dossier Preparation and Submissions in CTD format.
- Prepare Drug Master Files (DMF).
- Conduct Critical Review of Dossiers.
- Conduct Compliance audits as per current and updated statutory pharma regulations.
- Strategic assistance in Pharma Regulatory filing
- Listing drugs in SPL Metadata Format and Bulk Drug Listing.
- Assistance in Subcontracting Manufacturing or Testing Laboratories for Clients.
- Site Master File as needed by Local FDA.