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Filing a DMF for Timerx Controlled Release Systems with the U.S. FDA

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

  - Penwest Pharmaceuticals Co

Registrar Corp can help you to properly prepare and submit your Timerx Controlled Release Systems DMF to FDA.

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

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

For more information about filing a DMF for Timerx Controlled Release Systems, 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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