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

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

  - Hayashibara Co Ltd

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

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

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

For more information about filing a DMF for Trehalose, 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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