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Filing a DMF for Montanide ISA 51 with the U.S. FDA

Filing a drug master file (DMF) for Montanide ISA 51 can be a useful mechanism to market your Montanide ISA 51 to the U.S. Drug Industry. Typical Montanide ISA 51 producers who have filed a DMF for Montanide ISA 51 include:

  - Seppic Div Air Liquide

Registrar Corp can help you to properly prepare and submit your Montanide ISA 51 DMF to FDA.

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

  - Format, assemble and deliver your Montanide ISA 51 DMF to FDA
  - Submit letters of authorization regarding your Montanide ISA 51 to FDA
 - Provide changes, additions and maintenance of your Montanide ISA 51 DMF
  - Respond to issues relating to ownership of your Montanide ISA 51 DMF
  - Assist with submission of responses to FDA concerning your Montanide ISA 51 DMF
  - Perform any required annual updates for your Montanide ISA 51 DMF

For more information about filing a DMF for Montanide ISA 51, 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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