Our regulatory competencies are based on the types of submissions we make and how often we make.  In the past 12 months we have filed over a 100 submissions to CDER, CBER and CVM.

  • Filing of numerous INDs for CDER, CBER and INADs for CVM
  • Request numerous Type B and C Meetings within each Center
  • Successful Orphan Drug Designation
  • IND Life Cycle Management, Annual Reports, Protocol Amendments
  • File eCTD Drug Master Files (Type II and IV)
  • Navigate Expanded Use Initiatives
  • Navigate and Resolve IND Hold Issues
  • Develop Phase I Safety Assessment Programs for SAD and MAD Studies
  • Publication Management (clintirals.gov for US clients only)
  • IND Waivers; Pediatric Study Waivers; User Fee Waivers
  • IDE and 510k for Devices