FDA DMF Filing in eCTD format and US Agent for Drug Master File
What is drug master file- FDA DMF ?
A Drug Master File – or DMF – is a submission to the FDA that provides ‘confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs. Submitting a DMF is a complex process, and involves the gathering and submission of product-related technical information in an electronic common technical document filing format.
FDA reviews drug master file against pharmaceutical products application (NDA/ANDA) for which letter of authorization (LOA) from the DMF holder is required .
Types of DMF
United States Food and Drug Administration (FDA) has classified DMF in four types.
- PManufacturing Site, Facilities, Operating Procedures, and Personnel
- PDrug Substance (active pharmaceutical ingredients API), Drug Substance Intermediate, and Material Used in Their Preparation, or Drug Product
- PPackaging Material
- PExcipient, Colorant, Flavor, Essence, or Material Used in Their Preparation
- PFDA Accepted Reference Information
FDA has mandated to file DMF in the eCTD (electronic common technical document) format.
We offers a complete solution for all types of original Drug Master Filing, including amendments and Annual Reports. Our comprehensive services cover compilation, review, and technical gap analysis, drawing on over 15 years of experience of supporting companies across the globe.
Fees for DMF filing assistance start from as low as $399. Charges vary based on the nature of services required
Why choose our services for DMF Filing ?
If you have questions, please visit our FAQ section. Alternatively, you can contact us.
Remember : Failure to identify the right starting material or any other mistake may result in failure to pass the GDUFA Complete Assessment.