ORCA's team of Regulatory experts will help you achieve your business goals by advising you on your regulatory options on the road to product approval. Our team has extensive experience in all types of submissions and requirements of US FDA, including, but not limited to:
  • Designing the strategy for and implementing all types of FDA product approval submissions (IDE, PMA, HDE, 510(k), BLA,IND, NDA, ANDA)
  • Company Registrations
  • Acting as a US Agent for non-US companies
  • Manufacturing Site Registration
  • Compliance issues
  • Validation issues