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Regulatory Solutions

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, including:

  • 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

Get Regulatory Expertise Now

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


Camargo Pharmaceutical Services provides comprehensive drug development solutions, specializing in customized programs including the 505(b)(2) pathway.


Contact
Headquarters
9825 Kenwood Road
Suite 203
Cincinnati OH, 45242
Durham Office
800 Taylor Street
Suite 101
Durham NC, 27701
Montreal Office
507 Place d'Armes
Suite 1101
Montreal, QC H2Y 2W8, Canada
Phone 513.561.3329
Toll Free 888.451.5708
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