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Filing a DMF for Irgasurf Hl560 with the U.S. FDA

Filing a drug master file (DMF) for Irgasurf Hl560 can be a useful mechanism to market your Irgasurf Hl560 to the U.S. Drug Industry. Typical Irgasurf Hl560 producers who have filed a DMF for Irgasurf Hl560 include:

  - Ciba Corporation

Registrar Corp can help you to properly prepare and submit your Irgasurf Hl560 DMF to FDA.

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

  - Format, assemble and deliver your Irgasurf Hl560 DMF to FDA
  - Submit letters of authorization regarding your Irgasurf Hl560 to FDA
 - Provide changes, additions and maintenance of your Irgasurf Hl560 DMF
  - Respond to issues relating to ownership of your Irgasurf Hl560 DMF
  - Assist with submission of responses to FDA concerning your Irgasurf Hl560 DMF
  - Perform any required annual updates for your Irgasurf Hl560 DMF

For more information about filing a DMF for Irgasurf Hl560, 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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