J. Brian Xu, M.D., Ph.D., DABT®
Toxicologist
 

 
T: 908-393-9165
F: 202-557-3836
 
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EDUCATION:

M.D., Lanzhou Medical College, Lanzhou, China, 1982

Ph.D., George Washington University, Pharmacology/Toxicology, 1996

Postdoctoral Fellow, Yale University, Pharmacology, 1998

 
RANKINGS & RECOGNITION:

Diplomate of the American Board of Toxicology

 

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Dr. Brian Xu is a board-certified toxicologist with Bergeson & Campbell, P.C. (B&C®) who assists clients in developing and managing international projects involving U.S. Food and Drug Administration (FDA) and U.S. Environmental Protection Agency (EPA) regulated consumer products, cosmetics, industrial and specialty chemicals, agrochemicals, and antimicrobials. Dr. Xu is also an M.D. in pathology, holds a Ph.D. in pharmacology and toxicology, and has over 15 years of industry experience as a senior toxicologist and scientist at companies such as Ashland, Inc., Schering-Plough, and Merck.

Dr. Xu's significant experience with FDA and EPA regulations and the Orders and Decrees of the Chinese regulatory system helps him anticipate potential hurdles for clients registering or marketing products in either jurisdiction. Dr. Xu designs safety testing, risk assessment, product safety, and regulatory compliance programs that enable clients to market their products quickly and efficiently, and advises clients how not to solve problems in one jurisdiction only to create them in another. He works with clients to place, manage, and monitor toxicological and clinical tests and ensures Good Laboratory Practices (GLP) at laboratories in the U.S. and China; supports Globally Harmonized System of Classification and Labeling of Chemicals (GHS) classification and implementation; and oversees the preparation of dossiers in English or Chinese.

Representative Engagements:

  • Provided to a major multinational company toxicology and regulatory expertise in therapeutic and diagnostic products that combine drugs, devices, and biological elements.
  • Assisted in the preparation of China new chemical registrations for several large multinational companies, including evaluations and responses to inquiries about testing and analytical challenges.

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