Preclinical safety and regulatory compliance testing
WuXi AppTec provides an exceptional experience built on trust, quality and expertise, applying decades of accumulated knowledge to optimize your testing strategy and help prevent costly delays. We offer a broad range of preclinical safety and regulatory compliance testing to the highest international quality standards, making us the foremost choice for long-lasting partnerships with medical device manufacturers around the world.
We are a team of technical and regulatory experts applying innovative approaches to meet current requirements, including round robin testing for new assays. These progressive solutions are based on our unique depth of regulatory knowledge and proven track record of success—from developing test plans that satisfy preclinical endpoints, to executing exceptional submission strategies that meet the needs of your specific product.
We recognize that not all testing is straightforward, and we thrive when working with unique products and developing specialized testing plans or protocols to meet your individual needs. Above all, we stand behind our work—from test plans through clearance—responding to questions or other regulatory requests that may arise.
Technical & Regulatory Expertise
WuXi AppTec is committed to providing high-quality study data through our industry-leading testing solutions. For over 25 years, we have conducted hundreds of thousands of studies, from simple to complex devices, including combination products. We fully stand by our customers and our test results should you receive inquiries regarding your submission.
We operate in full compliance with International Standards Organization (ISO) quality system and laboratory guidelines, Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP) as applicable.
- 25-years’ experience
- Facilities in Saint Paul, Minnesota; Atlanta, Georgia; and a new facility in Suzhou, China
- More than 250,000 biocompatibility studies
- High throughput: 47,000+ sterility tests per month
- Work with 85% of major medical device companies