Quality

Avance Biosciences is committed to strict adherence to CGMP and GLP regulation and guideline set by US, European, and other internation regulatory agencies. We offer both regulated and non0regulated analytical and bioanalytical testing services to support regulatory submissions for pharmaceuticals and GMOs.

Our Quality Statement

Our quality system is meticulously designed and maintained to meet the most stringent requirements from regulatory authorities worldwide. It has been rigorously tested through numerous on-site client quality audits and is highly praised by our customers. Our quality system supports analytical and bioanalytical testing in compliance with FDA CGMP and GLP regulations, as well as EPA GLP regulations.

GMP Quality Statement

This project was conducted under the requirements of Current Good Manufacturing Practices as promulgated by the U.S. Food and Drug Administration 21 CFR Parts 210 and 211, ICH 02 (R1) Validation of Analytical Procedures: Text and Methodology, and EU EMA Eudralex Volume 4 and Associated Annexes, where applicable to the laboratory services provided. Avance Biosciences’ compliance with these regulations is defined in the Avance Biosciences Quality Manual and SOPs. The project documentation and report were reviewed for compliance with applicable cGMP. The results as presented accurately reflect the raw data.

GLP Quality Statement

This study was conducted under the requirements of Good Laboratory Practice as promulgated by the U.S. Food and Drug Administration 21 CFR Part 58, where applicable to the laboratory services provided. Avance Biosciences’ compliance with these regulations is defined in the Avance Biosciences Quality Manual and SOPs.

EPA GLP Quality Statement

This study was conducted under the requirements of Good Laboratory Practice as promulgated by the U.S. Environmental Protection Agency 40 CFR Part 160, where applicable to the laboratory services provided. Avance Biosciences’ compliance with these regulations is defined in the Avance Biosciences Quality Manual and SOPs.

Have Questions?

We are dedicated to timely, high-quality service from the start of your project to the finish. Send us a quick message with your questions to find out what Avance can do for you.