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Filing a DMF for Eudragits with the U.S. FDA

Filing a drug master file (DMF) for Eudragits can be a useful mechanism to market your Eudragits to the U.S. Drug Industry. Typical Eudragits producers who have filed a DMF for Eudragits include:

  - Evonik Rohm Gmbh

Registrar Corp can help you to properly prepare and submit your Eudragits DMF to FDA.

As your Agent, Registrar Corp will perform the following administrative functions:

  - Format, assemble and deliver your Eudragits DMF to FDA
  - Submit letters of authorization regarding your Eudragits to FDA
 - Provide changes, additions and maintenance of your Eudragits DMF
  - Respond to issues relating to ownership of your Eudragits DMF
  - Assist with submission of responses to FDA concerning your Eudragits DMF
  - Perform any required annual updates for your Eudragits DMF

For more information about filing a DMF for Eudragits, simply click below:

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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.
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