Drug Master File (DMF) Submissions - Overview
Drug Master File Submission (DMF submission) is not mandatory for the US FDA, as DMFs are neither approved nor disapproved. However, to maintain confidentiality in multiple DMFs, manufacturers/DMF holders file independent DMF submissions for drug substances/excipients/packaging materials.
To be compliant with the Generic Drug User Fee Act (GDUFA) II and Initial Completeness Assessment (ICA) requirements of the US FDA, DMF holders must ensure that their DMF is compliant with the FDA prerequisites. It is critical to get approval for the DMF application as it will enable the DMF holder to provide access to multiple applications such as IND/NDA/ANDA through a Letter of Access (LoA).
Freyr boasts of a highly skilled and committed Regulatory team that specializes in FDA Drug Master File (DMF) filing. Our team possesses extensive expertise in DMF submission and managing DMF for various components such as drug substances, excipients, and packaging materials in the US FDA.
Drug Master File (DMF) Submissions
- Regulatory submission strategy for different Drug Master File types such as:
- Drug Master File type II: Drug substance and drug substance intermediate.
- Drug Master File type III: Packaging materials.
- Drug Master File type IV: Excipient, colorant, flavor, essence, or material used in their preparation.
- Regulatory support in identifying the starting material.
- Guidance in the selection of the route of synthesis for the drug substance.
- Support for designing the limits for impurities in starting materials, intermediates, and their carry-over to Active Pharmaceutical Ingredients.
- Support in setting the strategy and limits for genotoxic impurities and elemental impurities in intermediates or drug substances.
- Review support in the finalization of the development report with Quality by Design (QbD).
- Guidance on designing the protocols for stability studies, process validation, hold-time study, and forced degradation studies for DMF submission.
- Review of executed batch manufacturing records for adequacy.
- DMF/Drug Master Files submission and DMF preparation in line with the GDUFA and ICA requirements for drug substances.
- Guidance for the GDUFA fee compliance.
- Publishing US DMFs in the eCTD format as per the current US FDA guidelines and requirements.
- Regulatory strategy, preparation, and submission of amendments and annual reports for registered Drug Master Files.
- Regulatory strategy, preparation, and submission of responses to Health Authority queries.
- DMF Filing Expertise.
- Creation of Drug Master File Template.
- DMF Preparation.
- Active Pharmaceutical Ingredient submission.
- Support in publishing US DMF.
