Quality Assurance

We have established a quality system that meets or exceeds worldwide regulatory standards from the U.S. FDA, EMA, NMPA and other major regulatory agencies. Starting with our Chief Executive Officer, our commitment to quality is ingrained in our company culture and our employees, which is one of our pillars of success for enabling our clients to bring novel biotherapeutics and vaccines into the clinic and beyond.

Our GMP manufacturing operations adhere to global regulations and guidelines including those from the FDA, EMA and NMPA. We have obtained Drug Manufacture License in 2020 and passed approx. 100 client GMP / quality audits in past 3 years and continue to strive and meet their stringent quality expectations.