Bridge (Vital Bridge)
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. Bridgeâ€™s Beijing facility was purpose built to conduct GLP studies in support of worldwide regulatory submission â€“ this goal has now been fully realized.
â€śThe FDAâ€™s acceptance of this data validates the wisdom of conducting preclinical research in China for clients looking to complete studies economically,â€ť said Tom Oakley, President and CEO, Bridge Laboratories. â€śWe are pleased about what this says about the quality of our work in China â€“ that it clearly meets Western standards â€“ and what it means to companies seeking cost-effective GLP IND-enabling work,â€ť 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 Beijingâ€™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 Bridge Laboratories
Bridge Laboratories is a US-owned, preclinical contract research organization (CRO) that provides US-level regulatory compliant drug development services globally. Bridge is headquartered in Gaithersburg, Maryland, with AAALAC accredited lab facilities in the US and Beijing, China. Bridge is known for its extensive work in toxicology; including vaccines, developmental and reproductive toxicology, and safety pharmacology. Bridgeâ€™s facility in China was among the first labs to perform GLP studies for clients worldwide.
Bridgeâ€™s existing facility in Beijing is the first Asian preclinical CRO with western-level attention to detail and includes one of the largest and most sophisticated animal vivariums in China. This facility was designed from the ground up to be both AAALAC multi-species accredited and US-level GLP compliant.... more