ASPHALION SERVICE “MINI PILL” | CMC solutions during Registration/Application

CMC (Chemistry, Manufacturing and Controls) is a fundamental requirement of all pharmaceutical applications to health regulatory agencies.​ At Asphalion, we offer customized CMC solutions depending on the status of your application.

CMC (Chemistry, Manufacturing and Controls) is a fundamental requirement of all pharmaceutical applications to health regulatory agencies.​ At Asphalion, we offer customized CMC solutions depending on the status of your application.
March 20, 2023

Our complete CMC services during registration/application include, among many others:

  • CTD Mod. 2 and 3 writing, review and/or updates for the EU and US
  • Dossier gap analysis
  • Due-diligence of in-licensing dossiers
  • Expert support on responses to deficiency letters
  • Expert reports.

Check out our #serviceminipill to see how ASPHALION can help you with CMC solutions during Registration or Application!

For further information, please contact us at: [email protected]

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