Regulatory Affairs

These are some examples of what we offer in Regulatory Affairs:

  • Regulatory strategy and advice in all phases of development
  • Preparation, review and management of regulatory submissions
    • CTAs, INDs, IMPDs
    • Orphan Drug Applications
    • PIPs
    • Scientific Advice / Protocol Assistance
    • MAAs / Variations /NDAs
    • Regulatory Agency Meetings
  • Preparation and attendance of Regulatory Agency Meetings

A number of Our People provide services in this area.