Services and expertise Include:
- Advanced Cell Therapies
- RegenMed
- Viral and non-viral vector systems
- Ex vivo modified cells
- Stem cells, iPSC technology
- Gene editing
- CAR-T cells
- Combination Products
- HCT/P 361 Products
- Interpretation of FDA regulations and guidelines
- Phase 1, 2, and 3 product development strategies
- FDA meetings: prepreIND, preIND, IND, BLA
- FDA submissions: prepreIND, preIND, IND and BLA, Master Files
- NIH, RAC process and submission
- Assessment of cGMP, cGTP and quality system compliance
- Due diligence assessment