The certification will allow WuXi to carry out non-clinical laboratory studies with respect to the requirements of the Chinese Food and Drug Act and SFDA GLP regulations.
The certification was based on a four-day inspection that included an audit of 16 studies in areas including productive toxicology (Segment I and II), carcinogenicity, safety pharmacology, dermal irritation, skin phototoxicity, vascular irritation, and immunology.
The company said facility inspection evaluated vivarium rooms, pharmacy, central archive, and laboratories relating to analytical chemistry, bioanalytical services, toxicokinetics, clinical pathology, histopathology, and immunology.
WuXi PharmaTech chief operating officer and chief financial officer Edward Hu said the receipt of the certificate is further acknowledgment that the company offer its clients non-clinical laboratory studies that meet national and international GLP quality standards.
"This award is additional confirmation of WuXi capability in offering our pharmaceutical and biotech clients a comprehensive, fully integrated platform of pharmaceutical R&D services," Hu added.