Email Address

info@dunnregulatory.com

Telephone

703-577-8291

Chemistry, Manufacturing and Controls (CMC)

Chemistry, Manufacturing and Controls (CMC)

Our knowledge and experience enables us to provide you with CMC regulatory strategy and consulting 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.

Our regulatory CMC services include:

  • Review of CMC documents to increase probability of success with the regulatory agencies
  • Consultation and response to CMC questions from regulatory agencies
  • cGMP compliance activities
  • Drug Master File (DMF) preparation and review
  • Evaluation of impurities
  • Review of manufacturing records
  • Mock facility inspections