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.

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.

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.

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.