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Quality Assurance

We have established a global quality system, quality control and operational systems that meet or exceed 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 and we have harmonized our quality assurance (QA) and quality management system across all sites around the world for the clinical or commercial production of biologics and vaccines drug substance and drug product. 

 

Our commitment to quality is one of our pillars of success for enabling our clients to bring novel biotherapeutics and vaccines into the clinic and beyond. To learn more, see our video outlining our premier, world-class quality system.

 

Our Quality Track Record

All of our GMP manufacturing operations adhere to global regulations and guidelines including those from the FDA, EMA and NMPA.  We currently have 11 different drug substance and drug product manufacturing facilities and quality control testing laboratories that have received GMP certifications.

We have passed over 760 client GMP / quality audits and continue to strive and meet their stringent quality expectations.  

We have passed 25 inspections from 9 different regulatory agencies including  the U.S. FDA, EMA, NMPA, PMDA, MFDS, HSA, ANIVSA, HPRA and Health Canada.

We have enabled our clients to successfully obtain 24 product license approvals related to BLA / MAA / EUA filings for 8 different products from 12 different regulatory agencies. 

Using our integrated DNA to IND biologics development and manufacturing platforms, we have successfully helped our clients from all around the world to successfully file over 315 Investigational New Drug (IND) applications since 2015.

For more information on our Quality track record see this infographic

 

Keys to Meeting Client Quality Assurance Expectations
 
WuXi Biologics utilize ALCOA+ data integrity principles, extensive employee training programs and an unwavering commitment to protecting our client’s IP as key components in our ability to provide a premier, world-class quality system that will enable our clients to provide novel biologics and vaccines for the benefit of patients worldwide.
 
 
 

Protecting our clients IP is a cornerstone of our quality programs and company culture.