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