Regulatory Affairs

  • Investigational New Drug (IND) application preparation and submission
  • Market Authorization Application (MAA) preparation and submission
  • New Drug Application (NDA) preparation and submission
  • National / MRP / DCP / CP registrations
  • Scientific Advice requests
  • Orphan Drug Designation requests EMA/FDA
  • Pediatric Investigation Plan (PIP) submissions
  • Pre-submission meeting preparation and support
  • Fast Track strategy support
  • Local representation in Switzerland, the European Union, and the United States
  • SME status application / Small Business Waiver / PDUFA
  • FDA advisory committee preparation
  • CHMP oral explanations
  • GDPR compliance check
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