Drug Master File (DMF)
A Drug master File (DMF) is a submission to the US FDA, AU-TGA, EU that may be used to provide confidential detailed information about facilities, processes or articles used in the manufacturing, processing, packaging and storing of one or more human drugs. KnowledgeNET is a Solution to create DMF for electronic submission in regulatory agencies. Regulatory are going mandatory in submission of DMF in eCTD format (eDMF) and has issued dates for submissions.
The information contained in the DMF may be used to support an Investigational New Drug Application (IND), a New Drug Application (NDA), an Abbreviated New Drug Application (ANDA), another DMF, an Export Application or amendments and supplements to any of these.
DMF publishing– US FDA system
The submission process is cumbersome but Sarjen with its off-the-shelf software, KnowledgeNET, and effective strategic consultancy has a number of successful DMF submissions to its credit. KnowledgeNET, a 21 CFR Part 11 compliant software, simplifies the complexity of the XML backbone structure. The system enables multiple users with an intuitive user-friendly interface and enhances cost and time effectiveness. Sarjen commits to being a good corporate citizen and proves a leverage in the Pharmaceutical and Life sciences businesses.
DMF software – special features
- Module 1 document mapping and granularity management
- DMF life cycle management including the amendments and annual report
- DMFs that cover multiple items, e.g., container closure systems (Type III) or Flavors (Type IV) in CTD
- Electronic Signatures in DMFs
- US FDA specific Document formatting and publishing
- Navigation Aid Management including the table of contents and hyperlinks
- Dossier assembly and compilation in eCTD format
- Paper to Electronic document conversion to provided searchable text based documents as required by US FDA
- For small sized API companies, we provide Pay per Dossier conversion to create eCTD based DMF submissions