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.