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Filing a DMF for Biosustane(R) SAIB with the U.S. FDA

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

  - Eastman Chemical Co

Registrar Corp can help you to properly prepare and submit your Biosustane(R) SAIB DMF to FDA.

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

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

For more information about filing a DMF for Biosustane(R) SAIB, 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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