CMC Regulatory Services

Externalized Supply Operations Management
Quality Systems Implementation and Management
CMC Regulatory Services
Specialized Technical Expertise
Corporate Support Activities
Sustainable CMC, Supply Chains and Operations
  • Writing of regulatory documentation packages supporting clinical development programs (IMPD, IND) or registration (CTD Module 3 and QOS: MAA, NDA, BLA) files
  • Submissions for the obtention of Certificates of Suitability with the European Pharmacopoeia monographs (CEP)
  • Interaction (written and meetings) with regulatory authorities (EMA, FDA, MHRA, EDQM) throughout all clinical development and registration stages
  • Compliance audits and successful support to site inspections (FDA)