Regions  

US Regulatory Services

US regulatory landscape is complex and at the forefront of driving global regulatory strategies. Our experts led Global regulatory programs achieving multiple regulatory approvals. We are specialised in multiple aspects of US regulatory affairs.atory strategies and execution.

  • US Regulatory Strategy
  • FDA meetings
  • IND Submissions
  • (s)NDA and (s)BLA Submissions
  • PMA Submissions
  • Post Marketing Commitment (PMC) Submissions
  • Paediatric Study Plans
  • ACCELERATE/Molecular Target List
  • Rare Disease/Special Protocol Assistance