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