Drug Master File (DMF) services

Malawer & Associates Consulting, LLC

Pharmaceutical, Chemical, & Dietary Supplement Value Creation

Drug Master File (DMF) Services

Our firm focuses on the development of drug master files for firms wishing to file such documents with the United States Food & Drug Administration (FDA). While DMF filing is not required by the FDA, it is highly encouraged by the Agency for firms seeking to incorporate their pharmaceutical ingredients into new and existing drug products.

Our services cover Type II DMFs for drug substances (APIs) and Type IV DMFs for excipients (inactive ingredients). All DMFs are prepared in the Common Technical Document (CTD) format stipulated by the FDA.

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1) Initial DMF Preparation and FDA Filing
Elements:

Provide a checklist to the client of U.S. FDA-required DMF components to be suppliedReview of technical documents provided by the client for completeness and readability
Communication with the client to address any missing or inadequate documents
Assembly of the DMF into the FDA-required format
Submit the completed DMF for review and acceptance by the client
Optional: printing the DMF in the FDA-required format for paper submission *
Submit the DMF to the FDA (either electronically or in paper form)
Submit letters of authorization to the FDA on behalf of the client, the DMF holder
Malawer & Associates Consulting, LLC acts as the U.S. agent for the client’s DMF
Electronic copy of DMF archived by Malawer & Associates Consulting, LLC

* Electronic formatting of DMF documentation is standard. Additional charges would apply for preparation of a paper-based DMF in the U.S. FDA required format.

Please contact our firm for our current attractive rate for DMF preparation and FDA filing. The rate presumes that the client’s technical documents are in English and are well-written. Additional hourly charges would be applied for extensive rewriting of any submitted documents into required DMF elements. Translation services (into English) cannot be provided.

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2) Annual DMF Maintenance
Elements:

Assist with the submission of responses to FDA concerning client’s DMF on file
Notify those authorized to refer to client’s DMF of any changes in advance
Provide DMF changes, additions, and deletions to the FDA
Perform required annual update for the client’s DMF on the submission’s anniversary
Submit any additional letters of authorization to the FDA
Assist in the closure of a DMF on file with the U.S. FDA, as required
In general, continue to act as the U.S. agent for the DMF holder if a non-U.S. firm

Please contact our firm for our current attractive rate for DMF maintenance. This price presumes that major changes to the client’s DMF are not required in any given year. The price for a major revision will depend upon the effort involved. The client would be notified before any work is discharged on a major DMF revision.

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Malawer & Associates Consulting, LLC has retained Conthera Pte Ltd. / Simplyceutics to act as its agent in order to directly interface with all potential clients in the Asian region. Asian firms interested in our DMF services are requested to contact that firm. Contact information is provided at the following website link:

http://www.simplyceutics.com/index.php?page=contactus

The FDA strongly advises foreign firms wishing to file DMFs with the Agency to utilize U.S.-based agents for both filing and required annual maintenance.