WHY WAISMAN
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)