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

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

  - Alkermes Inc

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

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

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

For more information about filing a DMF for Medisorb, 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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