Specific Services for the US

Our market specific services for the US

The Food and Drug Administration (FDA) is responsible for protecting and promoting public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products and medical devices.

Our US based consultants can help navigate FDA regulations and provide support and advice for all your project requirements. Specific services provided by our team in the US include:

  • Pre-Market Notification (510(k))
  • Pre-Market Approval (PMA)
  • Investigational New Drug application (IND)
  • New Drug Application (NDAs)
  • Biologic License Application (BLAs)
  • Pediatric Study Plans / Orphan Drug Designation
  • Submission to the FDA (Electronic Submission Gateway)
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