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Services
Strategic Regulatory Consulting Services, especially CMC/quality aspects:
- All stages of development
- Lifecycle management (variations, line extensions,…)
- Regulatory strategy in emerging markets
Operational regulatory support:
- Review and optimization of regulatory process
- Team management
- Optimization of submission plan
- Review of critical pieces of regulatory files (IND/IMPD/CTD/DMF/ ASMF,…)
- Preparation of answers to List of Questions (especially module 3)
- Preparation of meetings with Authorities (Agencies, EDQM,…)
- Regulatory due diligences and implementation plan
Training in Regulatory Affairs
- Tailored to your needs
- In French or English