Henlius has established a quality management system in line with international quality standards, which covers the entire product life cycle, from research and development to material management, product manufacturing, quality control, product supply management and particularly, product post-marketing surveillance, laying the foundation for globalisation.
Henlius’ fully operational manufacturing sites and supporting quality management systems have passed on-site inspections and audits conducted by the NMPA, the EMA, the FDA, the EU Qualified Person, as well as Henlius’ international business partners, and have been GMP-certificated by China, the EU and the U.S. regulatory agencies as well as various PIC/S participating members
Led by a quality management team rich in international working experience and underpinned by the “Quality-centric Culture”, Henlius will continue to redouble efforts in improving quality management system and operation efficiency.