Chemistry Manufacturing and Controls (CMC)
Regulatory Support

CMC Regulatory support at every stage of development, registration and life cycle management.

 

BlueReg experts will provide your company with CMC Regulatory support at every stage of the development.

  • Assessment / definition of the CMC development strategy
  • Writing of CMC sections of briefing books for health authorities meetings
  • Assessment / preparation of regulatory documents:
    • Investigational New Drug (IND) application
    • Investigational Medicinal Product Dossier (IMPD)
    • Active Substance Master File (ASMF) / Drug Master File (DMF)
    • Certificate of Suitability to the European Pharmacopeia (CEP)
  • Responses to agency questions

Our experts

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