Regulatory Services offered:
- 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 APIs and Packing materials.
- Assisting the clients for development of new products and data generation in line with country specific registration guidelines.
- Assistance in responding to queries for submission to the Regulatory Agencies.
- Regulatory Assistance in Post-Approval compliance
- Assisting the clients to upgrade the existing products by additional data generation to the requirements of updated regulatory requirements (Gap analysis).
The Mediviz Footprints of Operation:
- The European Union
- Asia Pacific
- Asian Countries
- All CIS Countries
- Middle- East
- African Countries
- Latin America