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.