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Toxicology Services

The Toxicology Unit at the Laboratory Testing Division is your full-service provider of preclinical and clinical stage safety assessments for biologic and small molecule drugs. Whether you require a four-week rodent study for an IND, or a two-year carcinogenicity study for an NDA, the Toxicology Unit has the scientific expertise, technical experience and regulatory understanding to handle your project to the highest international quality standards, no matter the scope or scale.

Service & Quality

Toxicology is fully integrated within our comprehensive testing platform, providing customers with the multidisciplinary expertise and experience that is inherent to WuXi. This approach not only yields significant time and cost savings, but the institutional knowledge gained when handling your project in its entirety is invaluable in terms of the data and insight we are able to provide. Our commitment to world-class quality has been validated by both government agencies and numerous clients around the world.

Suzhou, China
+ 317,000 square-foot facility
+ 170,000 square feet of storage and procedure rooms
+ 120 study rooms
+ HEPA-filtered, computer-controlled and monitored HVAC
+ Double-barrier study rooms to meet PMDA and CFDA requirements
+ State-of-the-art equipment and security

Track Record of Success

For nearly a decade, the Toxicology Unit has provided a full-scale testing platform for clients at all stages of drug development. Leveraging the translational expertise of our diverse teams of scientists, we have completed thousands of discovery, IND- and NDA-enabling studies for our global clients, while maintaining a nearly perfect record of on-time delivery.

+ Studies completed in over 20 countries
+ Over 300 IND / NDA packages submitted globally
+ Over 99% on-time delivery of study data and reports

Operations & Compliance

With strict adherence to Standard Operating Procedures (SOPs) that align with global regulatory guidelines, we consistently produce high-quality data that is accepted worldwide. Since its inception, the Toxicology Unit has maintained full AAALAC accreditation, and has had successful inspections by the FDA, OECD, CFDA and numerous client-sponsored audits for GLP compliance and animal welfare. Our management team and operations staff hail largely from international big pharma and CROs, and a significant number hold advanced degrees.

+ 400+ employees
+ Global regulatory compliance
– US FDA GLP
– OECD GLP
– CFDA GLP
– AAALAC
– Standard Exchange of Nonclinical Data (SEND)

Animal Health, Safety & Quality

We adhere to the highest industry standards in every study we conduct, and this begins with the animals. All of our animal vendors are audited by our veterinary and quality assurance staff to ensure our animals are happy and healthy, and that the data generated is accurate and reliable. We have received the highest accolades for “providing and maintaining an exemplary program of animal care.”

+ Animal welfare program oversight by attending veterinarian
+ Zero-tolerance policy for abuse of animal welfare
+ AAALAC-accredited vendors and facility
+ Exceed international requirements for animal safety and care
+ Dozens of GLP and animal welfare inspections completed