WuXi AppTec operates an FDA, CFDA and OECD-inspected, GLP preclinical safety centre in Suzhou, China, approximately 140 kilometres from Shanghai PuDong Airport.
The company has one of the largest GLP animal facilities in Asia with 314,000 with 120 rooms.
WuXi AppTec offers comprehensive toxicology services for global clients ranging from compound screening or selection, to GLP toxicity testing for IND/NDA submissions for both small and large molecules.
The company's services cover general toxicology, genetic toxicology, safety pharmacology, reproductive and developmental toxicology and immunotoxicology, in addition to in-house pathology services provided by our board certified pathologists.
Its management team has over 150 years of combined international experience in large pharmaceutical companies and clinical research organisations, including Charles River, Huntingdon Life Sciences, ITR, Novartis and SNBL Japan.
All management and study directors speak English and host pre-study meetings to ensure the effective logistical and scientific communications.
WuXi AppTec strives to be a dependable partner in drug development, rather than just a provider of outsourced services.
Since 2010, the company has completed over 140 IND/NDA packages or components for submission to regulatory agencies throughout the world. Reports are all provided in English, but can also be translated into Chinese for submission to the CFDA. All reports can now also be prepared in the FDA’s preferred SEND format as requested.
Quality Animals and Welfare: An Ethical and Scientific Imperative
WuXi AppTec subscribes to the philosophy that quality data begins with quality animals and a responsible animal welfare program.
Its toxicology facility is AAALAC-inspected and was proudly described as “an exemplary program of animal care” in our most recent inspection report. Its expects animal vendors to adhere to the same high standard. The company only uses quality vendors that pass rigorous inspections conducted by its QA and veterinary audit led by Scout Chou, V.M.D., an ACLAM-certified veterinarian.