Covance notches GLP nod from Chinese regulators
Covance ($CVD) picked up a Good Laboratory Practice Certificate for its Shanghai early development facility, a regulatory milestone the CRO says gives it a leg up on global competitors.
The site offers safety assessment, bioanalytical, in vivo pharmacology, and DMPK services to clients in China and around the globe. Covance says it's now the only global CRO with GLP certification from China's State Food and Drug Administration, a requirement for any site amassing data for a future drug approval in the country, a company vice president said.
"Our early development facility in Shanghai offers world-class quality and expertise to companies with testing needs in China and the Asia Pacific region," VP Honggang Bi said in a statement. "Partnering with Covance in China will provide the gateway for local and regional pharmaceutical companies to access global markets and help save clients' time and costs in their drug development process."
Covance opened the Shanghai shop in 2010, and its latest certification follows last year's nod from the Association for Assessment and Accreditation of Laboratory Animal Care and GLP win from Belgian regulators.
With competition over biologics, manufacturing and early stage R&D, China has become ground zero for a host of global CROs angling for a share of its growing market for outsourcing. Local outfits like WuXi PharmaTech ($WX) are expanding their capacities, and U.S. companies like Charles River Laboratories ($CRL) are spending time and money to establish themselves in the country.
- read Covance's announcement