Services

Drug Master File - DMF Services RELATED PUNCHLINE WILL APPEAR HERE

Drug Master File - DMF

Drug Master File is a technical documents containing CMC part – chemistry, Manufacturing & control of an Active pharmaceutical ingredient. Drug master file becomes a part of a registration dossier for finished product registration

PPC Provides following service in regards to Drug Master File


  • DMF compilation in CTD Format / Country Specific format.
  • Open & close part DMF writing
  • Review of DMF For Submission
  • Type II (Active Ingredient) DMF Preparation and submission to US FDA.
  • European Certificate of Suitability (CEP) submission and Preparation.
  • Canada Submission & Preparation.
  • PPC can also help you with Analytical Testing – Elemental Analysis, Validations, Stability, etc

Why work with us???

  • Over 20 Years of Industry Experience
  • Well Qualified Team
  • Have Submitted more than 50 US DMFs type II, Compiled and written more than 300 DMFs in CTD format for various pharmaceutical companies.