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

  • General Toxicology
  • Safety Pharmacology
  • Genetic Toxicology
  • Developmental & Reproductive Toxicology (DART)
  • Ocular Toxicology

Dedicated Toxicology Facility

Located just outside of Shanghai in Suzhou, China, our 580,000-square-foot toxicology center is one of the largest safety testing facilities in Asia. As an organization, we invest heavily in maintaining a state-of-the-art infrastructure and continuously exceed international standards for health and safety. The Toxicology Unit is equipped with backup electrical generators, on-site water treatment and best-in-class laboratory equipment to ensure the wellbeing of our animals and the quality of our data.

Suzhou, China

  • Over 580,000 square-foot facility
  • 220 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 600 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
    • NMPA GLP
    • AAALAC
    • Standard Exchange of Nonclinical Data (SEND)

Animal Health, Safety & Quality

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, NMPA 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.

  • 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