Drug Master File – DMFs
To become a Research-based International Regulatory Affairs and dossier development center
Drug Master File is a technical document containing CMC part – chemistry, Manufacturing & control of an Active pharmaceutical ingredient. The drug master file becomes a most important part of a registration dossier for finished product.
We helps to write DMF & S Part of dossier. We also provide parts of DMF like Impurity, Stability, AMV, PV and Specification, COA & MOA of API.
Seedling RA Solutions Provides the 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