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Filing a DMF for Panalane(R) Polybutene Products with the U.S. FDA

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

  - BP Amoco Chemicals

Registrar Corp can help you to properly prepare and submit your Panalane(R) Polybutene Products DMF to FDA.

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

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

For more information about filing a DMF for Panalane(R) Polybutene Products, 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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