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Filing a DMF for Softel C102M with the U.S. FDA

Filing a drug master file (DMF) for Softel C102M can be a useful mechanism to market your Softel C102M to the U.S. Drug Industry. Typical Softel C102M producers who have filed a DMF for Softel C102M include:

  - Basell USA Inc

Registrar Corp can help you to properly prepare and submit your Softel C102M DMF to FDA.

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

  - Format, assemble and deliver your Softel C102M DMF to FDA
  - Submit letters of authorization regarding your Softel C102M to FDA
 - Provide changes, additions and maintenance of your Softel C102M DMF
  - Respond to issues relating to ownership of your Softel C102M DMF
  - Assist with submission of responses to FDA concerning your Softel C102M DMF
  - Perform any required annual updates for your Softel C102M DMF

For more information about filing a DMF for Softel C102M, 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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