Regulatory Services

Jubilant Clinsys Inc. has significant experience in full-service regulatory consulting, especially in the areas of strategic drug development, FDA liaison activities, regulatory submissions and regulatory document review.

• Consulting Services
  • Drug/Device Development Strategy
• FDA Liaison Activities
  • FDA Meeting Packages
  • Preparation and Attendance at FDA Meetings
  • Authorized Representative to FDA (US Agent)
• Regulatory Submissions
  • IND/IDE Applications
  • Marketing Applications (NDA/BLA/NDS/MAA)
  • eCTD Compliant Publishing
  • International Safety Reporting
  • Orphan Drug Designation Requests
  • ANDA Applications
• Regulatory Review
  • ICFs
  • Regulatory Documents
  • Subject Recruitment Materials