Global GxP & Regulatory Services for Food,Drugs,Cosmetics & Medical Device Industries
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.
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..