- Clinical Synopsis, Clinical Protocol, Long-term Follow-up Protocol, Clinical Study Report
- Investigator Brochure (IB) and Informed Consent Form (ICF), Safety Update and Annual Report
- Support for Expedited Designation Applications: Fast Track Designation (FTD), Regenerative Medicine Advanced Therapy (RMAT), Orphan Drug Designation (ODD), and Rare Pediatric Disease Designation (RPDD)
- Click here for eCTD details, specifically the “Clinical module” section.
- Click here for a full list of supported regulatory documentation for clinical and beyond.
Other Clinical Submissions Support may include:
- iPSP (Initial Pediatric Study Plan)
- LTFU (Long-term Follow-up) Protocol for CGT
- Clinical Special protocol assessment (SPA); (M1.8)
- Annual Reports; (M1.13),
- Support with Navigation through IRB
- Indication landscape analysis: based on preclinical data, clinical data, market need
Support with regulator meeting packages may include:
- INTERACT, pre-IND
- EOP1, EOP2 (End-of-Phase meeting)
- Pre-BLA meetings
- FDA Type A, B, C, D
