All work at CUSTOM BIOLOGICS meets the highest standards of scientific integrity and is conducted in strict compliance with GxP regulatory guidelines. Our independent Quality Assurance Unit (QAU) guarantees that all work is performed in compliance with current good laboratory practice.  These high standards are met whether this work is intended for research and development or for submission to a regulatory agency.  Study-based audits as well as regular audits of our facility are routinely conducted.

Sample management and storage/retrieval is guided by a protocol-specific sample-handling system. This aspect of our quality system is monitored by a dedicated QAU representative to ensure prompt sample-receipt notification to all responsible parties.