A Drug Master File (DMF) is a submission to the regulatory authority( USFDA, EDQM, Canada, ROW Market)  that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs for the registration of the drugs in the respective regulatory agencies.

FWQRC™ facilitates for the preparation of dossiers for the following types of USDMF

  • Type I:  Manufacturing Site, Facilities, Operating Procedures, and Personnel
  • Type II:  Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation, or Drug Product
  • Type III: Packaging Material
  • Type IV:  Excipient, Colorant, Flavor, Essence, or Material Used in Their Preparation
  • Type V: FDA Accepted Reference Information

The EDMF/ ASMF is filed in the European Union either solely or based on the needs of the customer (Marketing Authorization holder). FWQRC provides assistance for the preparation, filing of the DMF. The following procedures involved in the filing of ASMF/EDMF in the EU region.

  • National Procedure
  • Centralized Procedure
  • De-centralized Procedure
  • Mutual Recognition Procedure

While, the DMF preparation for ANVISA  requires more information about the API than the filing of DMF for other regulatory agencies. The ANVISA guidelines are more elaborate than any of the others agencies. We assist for a one shot approval for the DMF with your MAH.

FWQRC™ also file the DMF in eCTD format for all the regulatory agencies. The services includes Filing of Annual reports, Amendments, revisions, renewals, baseline submissions etc..


Call Now Button