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Filing a DMF for Certiseal A-100 with the U.S. FDA

Filing a drug master file (DMF) for Certiseal A-100 can be a useful mechanism to market your Certiseal A-100 to the U.S. Drug Industry. Typical Certiseal A-100 producers who have filed a DMF for Certiseal A-100 include:

  - Mantrose Haeuser Co Inc

Registrar Corp can help you to properly prepare and submit your Certiseal A-100 DMF to FDA.

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

  - Format, assemble and deliver your Certiseal A-100 DMF to FDA
  - Submit letters of authorization regarding your Certiseal A-100 to FDA
 - Provide changes, additions and maintenance of your Certiseal A-100 DMF
  - Respond to issues relating to ownership of your Certiseal A-100 DMF
  - Assist with submission of responses to FDA concerning your Certiseal A-100 DMF
  - Perform any required annual updates for your Certiseal A-100 DMF

For more information about filing a DMF for Certiseal A-100, 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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