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Regulatory Services and Support

Camargo offers a full range of regulatory support, from initial strategy and submissions to meeting and working with the FDA. We can provide expert insight, help extend the reach of your in-house regulatory team, or handle everything as your regulatory department.

Our Regulatory Solutions Include

  • PIND preparation, submission and meeting attendance
  • IND, NDA, and ANDA preparation, submission and maintenance
  • eCDT Submissions
  • EOP1, EOP2, Pre-NDA, Advisory Committee preparation and meetings
  • Request for expedited designations
  • Request, preparation and submission for:
    • Orphan Drug Designation (ODD)
    • Rare Pediatric Disease Designation (RPDD) and Voucher (RPDV)
    • Qualified Infectious Disease Product (QIDP) designation
  • Type A, B and C meeting requests
  • Special protocol assessments
  • Pediatric Study Plans (iPSPs) and Pediatric Investigation Plans (PIPs)
  • Investigational Medicinal Product Dossiers (IMPD) and other international regulatory documents

To learn how you can benefit from our regulatory support expertise, Contact Us.