Filing a drug master file (DMF) for Gelatin can be a useful mechanism to market your
Gelatin to the U.S. Drug Industry. Typical Gelatin producers who have filed a DMF for
Gelatin include:
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Nitta Gelatin India Ltd
Registrar Corp can help you to properly prepare and submit your Gelatin DMF to FDA.
As your Agent, Registrar Corp will perform the following administrative functions:
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Format, assemble and deliver your Gelatin DMF to FDA
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Submit letters of authorization regarding your Gelatin to FDA
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Provide changes, additions and maintenance of your Gelatin DMF
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Respond to issues relating to ownership of your Gelatin DMF
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Assist with submission of responses to FDA concerning your Gelatin DMF
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Perform any required annual updates for your Gelatin DMF
For more information about filing a DMF for Gelatin, simply click below:
U.S. FDA Regulations:
U.S. FDA DMF Regulation: 21 C.F.R. Section 314.420
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.
