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Fees: Drug Master File (DMF) submissions
Companies wishing to submit a drug master file must designate an Agent for FDA communications. As your Agent, Registrar Corp's team of drug regulatory experts provides guidance as to required elements, formats and particularities of drug master file submissions for US$ 995 annually including:
Format, assemble and deliver your DMF to FDA
Submit letters of authorization to FDA
Provide changes, additions and maintenance of your DMF
Respond to issues relating to ownership of your DMF
Assist with submission of responses to FDA concerning your DMF
Perform any required annual updates for your DMF
Registrar Corp assists businesses with U.S. FDA compliance. Certificates of Registration issued by Registrar Corp provide confirmation to industry that you are fulfilling U.S. FDA registration requirements. U.S. FDA does not issue or recognize Certificates of Registration. Registrar Corp is not affiliated with the U.S. Food and Drug Administration.
