Covance Inc. has announced that its early development facility located in Shanghai, China, has received a Good Laboratory Practice (GLP) Certificate from the State Food and Drug Administration (SFDA) of the People's Republic of China.
The Covance facility in Shanghai provides nonclinical safety assessment, bioanalytical, in vivo pharmacology, and DMPK services.
Since opening its early development facility in Shanghai in August 2010, Covance has secured several key accreditations from international regulatory bodies.
In February 2011 the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) awarded full accreditation to the company's early development research facility.
The company also received GLP certification from the Belgian GLP Monitoring Authority, a member of the Organization for Economic Cooperation and Development (OECD), in September 2011.
The most recent accreditation from the SFDA demonstrates that Covance continues to invest in China to offer its clients a full range of expert nonclinical and chemistry services.
"Covance is now the only global CRO with SFDA GLP certification in China. Our early development facility in Shanghai offers world-class quality and expertise to companies with testing needs in China and the Asia Pacific region. Partnering with Covance in China will provide the gateway for local and regional pharmaceutical companies to access global markets and help save clients' time and costs in their drug development process," said Honggang Bi, Corporate Vice President and General Manager, Covance China.
"Covance's early development facilities offer a comprehensive range of nonclinical drug development services to clients around the globe, helping them make fast and effective drug development decisions to progress their most promising product candidates. In addition to our early development facility in Shanghai, we also offer clinical and central laboratory services to clients across Asia, making Covance the only CRO with the expertise to develop a molecule from discovery through all preclinical and clinical milestones. We believe this makes Covance a 'one stop shop' for companies wishing to develop drug candidates in Asia and across the globe," added Steve Street, Global Vice President and General Manager, overseeing Covance's worldwide safety assessment and pharmaceutical chemistry services.