Press Releases

Bridge Laboratories' China Study Data Accepted by the FDA

Bridge Laboratories announced today that the FDA has accepted data submitted from its Beijing facility on behalf of a US biotech client. The Good Laboratory Practices (GLP) nonhuman primate toxicology study data was generated and submitted last month as part of an IND package to the FDA. Bridge’s Beijing facility was purpose built to conduct GLP studies in support of worldwide regulatory submission – this goal has now been fully realized.

"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 CEO, 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.

Foreseeing the opportunity for China-based GLP-compliant preclinical services several years ago, Bridge Laboratories began planning a preclinical services laboratory located in Beijing’s Zhongguancun Life Science Park. This state-of-the-art laboratory, the first in China built from the ground up to meet international GLP-compliant standards, opened in 2006. Bridge recently announced that they are in the process of developing a second facility which is expected to be completed in late fourth quarter 2009. The new facility will be adjacent to the existing one in Beijing, will quadruple the available laboratory space, and will allow Bridge to continue to expand their service offerings for clients worldwide.

About Pharmaron

Founded in 2003, Pharmaron is a leading pharmaceutical and biotechnology drug R&D CRO, with operations in China and the United States. Clients include pharmaceutical, biotechnology, academic and government organizations. As a research-driven and customer-focused company, Pharmaron provides a broad, integrated portfolio of laboratory and manufacturing services from drug discovery to IND submission. These services are designed to help its global partners improve the success of research and shorten the time of development cost effectively in discovering and developing drugs. For more information about Pharmaron, please visit http://www.pharmaron.com.