WuXi AppTec offers in-vivo and in-vitro non-clinical safety evaluation programs tailored to meet the unique needs of biologics, medical devices, combination products and their constituent components. As the uniqueness of each product requires a case-by-case approach, we partner with clients to ensure that all study components meet specific program objectives.
Testing services are based on the current global regulatory guidelines and requirements, and our quality systems have been audited and accepted by regulatory authorities worldwide. WuXi AppTec scientists have extensive experience in designing non-clinical safety testing programs, and our services have supported a number of successful regulatory submissions in the U.S., Europe and Asia.
St. Paul Facility
Building on our many years of experience providing quality testing services to the pharmaceutical, biologics and medical device industries, WuXi AppTec is continually growing and enhancing its toxicology program at its St. Paul facility.
WuXi AppTec’s scientists and staff have extensive experience in designing, developing, and conducting testing programs. The St. Paul facility is FDA registered and ISO 17025 certified. Additional qualifications include AAALAC and AALAS accreditation, and USDA and DEA licenses.
With WuXi AppTec’s depth of expertise and its expanded facilities, including on-site clinical pathology, on-site histopathology, and on-site QA, our clients are assured they will receive the highest level of service for their toxicology studies.
Acute Toxicity (in-vivo)
Repeat Exposure (in-vivo)
Genotoxicity (in-vitro and in-vivo)
In-vitro Bacterial Mutagenicity
Available Animal Models
Mice (athymic and normothymic)
Dose Administration Routes
For more details on available testing services, click here to access the Catalog of Services for Devices and Combination Products.