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Toxicology


Toxicology (TOX)

Ensuring Safe and Reliable Pharmaceutical Products

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The Toxicology Unit provides a full preclinical safety assessment via non-GLP exploratory studies or GLP, IND-enabling studies for both small molecule drugs and biologics. Since our inception in 2009, we have worked with clients from over 20 countries around the world and completed ~140 IND/NDA packages for submission to all the major regulatory agencies. As seen in the timeline below, our facility has passed inspections from the FDA, CFDA, OECD and AAALAC, even receiving the highest accolades for “providing and maintaining an exemplary program of animal care.” This stems from the emphasis we put on animal quality and welfare as poor quality animals will inevitably lead to poor quality data. At ~314,000 ft2, our nonclinical safety center in Suzhou, China (just outside Shanghai) is one of the largest in Asia and is available to work on your studies 24/7/365. We welcome you to visit us anytime.

Animals and Animal Welfare
All our animals come from reputable vendors that are audited by our veterinary staff which is lead and trained by our on-site ACLAM board-certified veterinarian. (Learn More)

Summary of Study Offerings
Complete IND/NDA-enabling toxicological profiling. (Learn More)

Software and Reports
Automated data collection and comprehensive analysis yields reliable, submission-ready regulatory documents. (Learn More)