Quality Assurance

Our independent Quality Assurance Unit (QAU) implements the latest regulatory guidelines for bioanalytical and biological assay validation, and routine scientific analysis to ensure the quality, traceability and integrity of the data. These high standards are met for work conducted in the course of research and development or for submission to a regulatory agency.

All work at Custom Biologics™ is conducted in strict compliance with Good Laboratory Practice quality principles in a state-of-the-art facility fully compliant with FDA guidelines, 21 CFR Parts 11 and 58.