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.