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 (clintrials.gov for US clients only)
- IND Waivers; Pediatric Study Waivers; User Fee Waivers
- IDE and 510k for Devices