Talk to an Expert
about your upcoming project to see how we can help you
Global Bioanalytical Solutions
With WuXi AppTec as your partner, you have access to our highly experienced team of experts to help you move your molecule to the next milestone. As an extension of your lab, our team offers a customized approach that meets your dynamic needs, from study design to submission.
You can leverage our state-of-the-art facilities with the latest instruments and technology platforms. Our team of experts are committed to delivering quality results that help you navigate through your scientific and regulatory journey.
Global Bioanalytical Staff
Global Clinical Trials Supported
Bioanalytical Samples Analyzed/Year
Novel Compounds Supported/Year
Industry Leading Services for your Drug Development Journey
Whether it is small molecule innovator, generic PK studies or complex large molecule therapeutics PK, ADA, or Nab studies, our bioanalytical team works closely with clients across the globe to design a fit-for-purpose solution to accelerate your program. Our diverse range of bioanalytical services support discovery, preclinical and clinical phases of development. The bioanalytical strategies are designed to establish, and execute the right assays for a successful regulatory submission – IND or NDA.
- Supporting Your Drug Discovery and Non-regulated Bioanalysis
- Seamlessly Moving Your Program from Discovery to Regulated Preclinical Bioanalysis
- Generating Clinical Bioanalytical Data for All Clinical Trials
Dedicated Global Facilities
Our state-of-the-art facilities throughout Asia and North America offer regional flexibility and worldwide expertise and capabilities to support your global drug discovery and development journey with end-to-end bioanalytical solutions to meet your dynamic needs.
The first GLP laboratory in China to pass inspections by the U.S. FDA, NMPA and EMA, our bioanalytical lab in Shanghai maintains a clean regulatory track record, and has passed numerous GLP Quality assurance audits.
- GLP inspection and certification by OECD health authorities
- U.S. FDA and EMA compliance
- China FDA provincial compliance
- Data accepted by worldwide health authorities
Located within our state-of-the-art toxicology facility, the Suzhou bioanalytical lab supports toxicology services for our global clients. The Tox Bioanalytical Services Unit has consistently passed inspections by the FDA, NMPA and OECD.
- GLP Inspection and audited by NMPA, U.S. FDA and OECD health authorities
- On-site support for all in vivo GLP Tox studies and PK studies
- Integrated study flow from PK to Tox and Safety Pharmacology
Plainsboro, New Jersey
For nearly 30 years, the New Jersey bioanalytical facility has maintained a strong record of successful regulatory submissions and agency auditing records, which is supported by our standardized training, documentation and reporting systems.
- Strong regulatory audit history
- Regularly inspected by U.S. FDA
- Yearly / biannual repeat site qualification for major innovator and generic pharma
- 100% of data accepted by clients and regulatory authorities
Meeting All Regulatory Requirements for your Submission
WuXi AppTec’s established quality assurance infrastructure meets all global regulatory guidelines and GLP requirements. The Bioanalytical team have a proven track record of successfully global regulatory inspections and data is accepted by worldwide health authorities.