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