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Drug Master File (DMF) Submissions

The US Food and Drug Administration (FDA) neither requires nor discourages the submission of Drug Master Files (DMFs). Manufacturers and DMF holders must submit separate DMFs for drug substances, excipients, and packaging materials to ensure patient privacy.

DMF holders are responsible for ensuring that their DMF satisfies all FDA requirements, including those pertaining to the Generic Drug User Fee Act (GDUFA) II and the Initial Completeness Assessment (ICA). The DMF application must be approved so that the DMF holder can issue a Letter of Access for access to other applications, such as an IND, NDA, or ANDA.

The Regulatory team at E&E Medicals is highly qualified and dedicated to their work in submitting FDA Drug Master Files (DMFs). Our staff has experience submitting and managing DMFs to the US FDA for various drug components, including drug substances, excipients, and packaging materials.

DMF Submission

Submission strategy for various Drug Master Files to regulators, including but not limited to:

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.
Help from regulators in figuring out what the raw materials are.
Help in deciding which synthetic method to use to create the active pharmaceutical ingredient.
Contribution to developing impurity limit specifications for APIs, API precursors, and API derivatives.
Help determine the approach and acceptable levels of genotoxic and elemental impurities in drug intermediates and active pharmaceutical ingredients.
Quality by Design review assistance during report completion (QbD).
To submit a DMF, you will need instructions on designing stability studies, process validations, hold-time studies, and forced degradation studies.
Checking the completeness of the production batch logs that have been executed.
Drug Substance GDUFA and ICA DMF/DMF Submission and DMF Preparation.
Instructions for meeting GDUFA fee requirements.
eCTD publication of US DMFs as required by the Food and Drug Administration (FDA) as of December 2016.
Amendments and annual reports for registered Drug Master Files, as well as regulatory strategy surrounding their submission.
Planning, developing, and submitting regulatory submissions, including annual reports and updates to registered Drug Master Files.

DMF Submission

DMF Filing Expertise.
Creation of Drug Master File Template.
DMF Preparation.
Active Pharmaceutical Ingredient submission.
Support in publishing US DMF.