Other products & services we offer
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.
