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Filing a DMF for Sorbitol Special (Plasticizer) with the U.S. FDA

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

  - Spi Pharma

Registrar Corp can help you to properly prepare and submit your Sorbitol Special (Plasticizer) DMF to FDA.

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

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

For more information about filing a DMF for Sorbitol Special (Plasticizer), 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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