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Filing a DMF for Softisan 378 with the U.S. FDA

Filing a drug master file (DMF) for Softisan 378 can be a useful mechanism to market your Softisan 378 to the U.S. Drug Industry. Typical Softisan 378 producers who have filed a DMF for Softisan 378 include:

  - Condea Chemie Gmbh

Registrar Corp can help you to properly prepare and submit your Softisan 378 DMF to FDA.

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

  - Format, assemble and deliver your Softisan 378 DMF to FDA
  - Submit letters of authorization regarding your Softisan 378 to FDA
 - Provide changes, additions and maintenance of your Softisan 378 DMF
  - Respond to issues relating to ownership of your Softisan 378 DMF
  - Assist with submission of responses to FDA concerning your Softisan 378 DMF
  - Perform any required annual updates for your Softisan 378 DMF

For more information about filing a DMF for Softisan 378, 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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