The best chance at a successful drug submission begins—and ends—with a robust pharmaceutical quality system.

Pharmaceutical quality systems (PQS) are critical to ensuring drugs are manufactured to meet quality and performance standards as mandated by regulatory authorities globally. In fact, pharmaceutical quality is so important that during FDA inspections, the PQS is assessed as a key factor for supporting drug submissions.

At Custom Biologics, we boast a world-class PQS. 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.