OUR SERVICES

Regulatory

Aroga's document types include (but are not limited to):

  • Clinical CTD summary documents for marketing applications (eg, NDAs and BLAs)
  • INDs
  • Regulatory Responses
  • Briefing Packages
  • Pediatric Study Plans/Pediatric Investigational Plans
  • Orphan drug applications/European Orphan Medicinal Product Designation (OMPD)