Hengyu Biotech has always regarded the establishment of a quality system as the core goal and elements of the Company's development, and strives to provide reliable quality system support and assurance for first-class testing services under the quality policy of "Scientific Methods, Standard Operations, Impartial Behavior, Accurate Results, Customer Satisfaction, and Continuous Improvements". Already, Hengyu Biotech has achieved the UKAS ISO9001 quality management system certification, and is making continuous improvements to meet the compliance requirements of CNAS and GxP.
Hengyu biotech will support our partners in drug R&D, production and testing.
ISO9001
Hengyu Biotech underwent and passed the SGS on-site audit in April 2021, and obtained the UKAS ISO9001:2015 quality management system certificate on May 1, 2021. This shows that the Company's QMS level has obtained the International certification and reached a new level. In the future, Hengyu Biotech will continue to build and strengthen its quality management system to achieve continuous improvement of its capabilities and standards.
CNAS
Hengyu Biotech officially submitted the application for CNAS laboratory/testing agency accreditation in January 2022. After document review, on-site laboratory review and remote review, Hengyu Biotech was awarded approval in September 2022 and obtained the CNAS quality management system certificate in the same month. The experts of the review panel fully recognized Hengyu Biotech's laboratory layout design, first-class software and hardware level, professional staff, precise and effective methods, excellent capability validation, systematic supplier management, and biosafety, etc. Hengyu Biotech will continue to develop all aspects of innovative drug R&D and testing to safeguard life and health.
GMP
Hengyu Biotech serves its customers with top compliance standards, and continuously improves its system compliance in accordance with the requirements of Chinese and foreign GMP regulations. Since its operation, it has experienced dozens of various audits, and proved to meet the GMP compliance requirements for innovative pharmaceutical companies in various quality modules such as system operation, laboratory management, data management, facility and equipment management, validation management, supplier and material management, assisting customers to win sponsorship and commercialization of products as soon as possible.
GLP
Hengyu Biotech is promoting the establishment of a GLP quality system in accordance with the OECD Principles of Good Laboratory Practice (OECD Council [C(97)186/Final]), and FDA's Good Laboratory Practice for Nonclinical Laboratory Studies (21 CFR Part 58). Hengyu Biotech will continue its commitment to becoming a third-party testing laboratory that complies with international GLP quality management standards, and providing one-stop services for domestic and foreign biomedical companies, including viral clearance and inactivation studies validation, cell line characterization, and other biosafety analysis and testing.
Regulatory filing
Biosafety Level 2 (BSL-2) filing
Biosafety Level 2 with Enhanced Practices (BSL-2+) filing
