Services of DMFs
Drug Master Files (DMFs) are submissions to Food and Drug Administration (FDA), used to provide confidential, detailed information about facilities, processes or articles used in the manufacturing, processing, packaging and storage of human drugs.
The information contained in DMFs can 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 revisions and supplements to these applications.
DMFs activation only occurs during the stage of administrative review, and no fees need to be paid to the official. As long as the administrative review is approved, it will be activated. The DMF list is available on the official website and is updated quarterly.
US law or FDA regulations do not require the submission of a DMF, and the submission of a DMF is entirely at the discretion of the holder.
Our services include but are not limited to:
Guidance and writing of M1 template and M3 outline;
M2 production and professional translation services;
Guidance for DUNS Number and ESG (Electronic Submissions Gateway) applications;
Conversion and submission of application dossiers in eCTD format;
US agent services;
DMF annual report and change maintenance related services.
