Régulatory services
- Due diligences / Technical, regulatory and strategic audits of products, health products and/or the pharmaceutical laboratory ✱ ✱
- Regulatory strategy for any health product and regulatory requirements ✱ ✱
- Preparation of Scientific Advice meeting ✱ ✱
- Regulatory support for :
- Development, preparation and compilation of registration dossiers for all types of European procedures (national/decentralized/mutual recognition/centralized procedures)✱
- Preparation of registration files adapted to all Latin American countries ✱
- Regulatory maintenance (type IA, IB, II variation, MAT, transfert « Exploitant »)✱ ✱
- Submission of files, registration follow-ups, ARD ✱ ✱
- Review of packaging materials ✱ ✱
✱ France
✱ Latin America