The FDA has accepted data submitted from Bridge Laboratories‘ Beijing facility on behalf of a U.S. biotech client. The GLP nonhuman primate toxicology study data was generated and submitted as part of an IND package to the FDA. Bridge’s Beijing facility was built to conduct GLP studies in support of worldwide regulatory submissions.
   
“The FDA’s acceptance of this data validates the wisdom of conducting preclinical research in China for clients looking to complete studies economically,” said Tom Oakley, president and chief executive officer, Bridge Laboratories. “We are pleased about what this says about the quality of our work in China – that it clearly meets Western standards – and what it means to companies seeking cost-effective GLP IND-enabling work,” Oakley continued.
   
Bridge is in the process of developing a second facility in Beijing, which is expected to be complete in 4Q09. The new facility will be adjacent to the existing one and will quadruple the available lab space.