A Drug Master File is a submission to FDA that may be used in support of pre-market submissions to provide confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more drugs. Metti FDA Corp’s team of Regulatory Specialists provide guidance as to required elements, formats, and particularities of Drug Master File submissions.

Adverse Events

U.S. Adverse Event Contact for OTC Labels $600
Outsourcing Facilities
Registration and Registrant Contact

Self-Identification for Generic Drug Establishments

Self-Identification Submission $1,595

Third-party Logistics (3PL) and Wholesale Drug Distributors (WDD) must report to FDA between January 1 and March 31 of each year.

Call us for pricing Detention Assistance

Metti FDA Corp’s fee for detention assistance is dependent on the cause of detention. Contact Metti FDA Corp for pricing.

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Export Certificate to Foreign Governments
Export Certificate
FDA charges additional fees based on the type of certificate

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