Hengyu Biosciences relies on international compliance standards, leverages excellent quality and technical strength, and has built a one-stop Biosafety service platform focusing on large molecule drugs and CGT drugs. It has passed the EU QP, CNAS, and ISO9001 audit certifications, meeting the strict requirements of global regulatory agencies such as NMPA, FDA, and EMA, providing reliable assurance for innovative pharmaceutical companies. Hengyu Biosciences has served nearly 300 biopharmaceutical companies, with rich experience in project and application, and has helped 70+ projects, including ~40 Sino-US dual-reporting projects and 20+ BLA and Commercialization Projects, to obtain clinical and market trial approvals, offering services such as virus clearance validation, cell bank identification, commercial batch release, replication-competent virus (RCL, rcAAV, RCR, etc.) testing, and services such as HCD and HCP kit and testing.

Hengyu Biosciences has a team of technical and quality professionals with practical experience, using advanced systems and management systems, including LIMS and EMS systems that comply with ISPE GAMP5 management requirements, and has established a data management system that follows the ALCOA+ principle. Whether it is the IND, BLA application or the full life cycle management of commercial production of biopharmaceuticals, Hengyu can provide reliable biosafety and quality control support, providing strong assurance for the success of its customers.