Waisman has extensive experience in cGMP production of biologics for phase I/II human clinical trials including:




In addition, Waisman provides comprehensive Chemistry, Manufacturing, and Control (CMC) support for Investigational New Drug (IND) filings including:

  • Process development
  • Assay development
  • Process qualification/validation
  • Assay qualification/validation
  • cGMP manufacturing of pre-clinical and clinical material
  • Quality Control testing
  • Full CMC documentation including Facility Master File (CBER/CDER)