Regulatory assistance

Trasis guarantees its customers fast and reliable technical and regulatory assistance.
We can provide a set of various services, including :

  • Complete regulatory documentation such as ASMF/DMF
  • Consultation about our production and product use, equipment & products regulatory classification, analytical method development …
  • Support you during regulatory processes
  • Preparing documentation of compliance with applicable regulations
  • Design and performance of stability studies
  • We have DMF type V number  031001 devoted to AllinOne synthesizer deposited at US FDA. We can provide a letter of authorization for your NDA, ANDA or IND.

 

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