Chemistry, Manufacturing and Controls (CMC)

Our knowledge and experience enable us to provide you with CMC regulatory strategy and document preparation services. By partnering with us, you benefit from our extensive knowledge of the global CMC regulatory environment, and our experience in engaging with domestic and international regulatory agencies.

CMC Regulatory Activities:

  • Preparation of eCTD modules for INDs, NDA/BLAs and MAAs
  • Modules 2.3 and 3
  • Review of CMC documents to increase probability of success with the regulatory agencies
  • Consultation and response to CMC questions from regulatory agencies
  • Drug Master File (DMF) preparation and review
  • Safety evaluation of impurities
  • CMC project management

CMC Compliance and CMO Management:

Our consultants have the expertise to ensure your products are manufactured to cGMP compliance and local regulatory standards. We can provide:

  • Review of manufacturing records
  • Mock facility inspections
  • cGMP compliance activities
  • Management of CMOs