Regulatory Affairs


Our expertise in international regulatory affairs will help you navigate any regulatory hurdle, leading to resolution through negotiation.

  • Regulatory Strategies
  • Orphan Drug/Medicinal Product Designation (ODD, OMPD) applications
  • Scientific Advice/Protocol Assistance briefing packages
  • Paediatric Investigational Plans (PIP)
  • Background documents for FDA Type C, Pre-IND and Pre-NDA meetings
  • Preparation for and participation in meetings with Competent Authorities
  • Accelerated Pathways designation applications
  • Investigational New Drug (IND) applications and amendments
  • CTD templates preparation
  • Marketing Authorisation Applications (MAA)
  • New Drug Application (NDA)
  • Responses to regulatory questions/Information Requests
  • Variations/Post-Approval Changes