A Global CRO

 

Regulatory Affairs

Amarex's regulatory department has vast experience working with competent regulatory authorities around the world. Our expertise ensures that regulatory strategies are considered at every step to help gain product registration.

Our services include:

  • FDA meetings and presentations including company representation before regulatory officials
  • Pre-submission review of technical documents
  • Regulatory strategy creation
  • Marketing Application Support (NDA, BLA, ANDA, 510(k), PMA, etc.)
  • Clinical trial applications and notifications (IND, IDE, CTX, etc.)
  • Orphan Drug, Treatment Use, and ANDA Suitability petitions
  • Chemistry & Manufacturing Controls (CMC) consultation for FDA compliance
  • Review and support of manufacturing/GMP issues
  • U.S. Agent to FDA for our clients
  • Mock FDA and MHRA regulatory inspections