WHY WAISMAN Quality Management

Waisman's Quality Assurance (QA) group plays a key role in supporting all aspects of production and testing of clinical material under current Good Manufacturing Practice (cGMP) guidelines. We insure that all projects are compliant with applicable cGMP guidelines and the Waisman Quality System. The Waisman Quality System provides comprehensive documentation of polices and procedures that cover all aspects of facility operation, manufacturing, and quality control testing. The resulting manufacturing batch records and associated documents provide full traceability and records that are critical in demonstrating cGMP compliance and supporting Investigation New Drug (IND) and Investigation Device Exemption (IDE) applications.