Press Releases

Bridge Successfully Validates Beijing Preclinical Laboratory

September 6, 2006 - San Francisco, CA

Bridge, with the assistance of Barry-Wehmiller Design Group and Instem, has successfully validated the first phase of instrumentation, HVAC/BMS systems and its Provantis data acquisition software for full FDA Part 11 compliance.

Bridge Laboratories, the leading preclinical Contract Research Organization in Asia, announced that its preclinical testing laboratory in Zhongguancun Life Science Park in Beijing, China has completed the first of two validation phases of all instrumentation, software and air handling and BMS systems. This state of the art facility, one of the largest and most advanced vivariums in China, is currently the only preclinical laboratory in China to have US level GLP validated systems and software.

"The validation of the instrumentation, air handling systems, environmental control systems and data acquisition software is a result of the tremendous effort and dedication of the management and staff of this facility along with the regulatory experts of BW Design Group and Instem's Provantis validation team." commented the EVP and CTO of Bridge. "This completes a major step for Bridge's Beijing facility towards becoming the first and only US level GLP compliant preclinical laboratory in China."

Bridge is dramatically lowering research and development costs for Western biopharmaceutical companies, while delivering the highest quality standards of study data that can be submitted to any regulatory agency in the world, including the U.S. Food & Drug Administration.

"Instem is pleased that we could provide a rapid deployment and validation plan for our latest Provantis data acquisition software to place Bridge at the forefront of preclinical drug development in China." commented Phil Reason, CEO at Instem. "This is one of the fastest deployments on record of our system, and we are confident our relationship with Bridge will set the standard for the future of preclinical development in China."

"Our team has worked interactively with the Bridge preclinical staff to assess a majority of the facility's systems and instruments for full Part 11 compliance" commented Howard Treadaway, Manager of Regulatory Services for BW Design Group. "Upon completion of the remaining systems and instruments during the second phase in December, 2006 Bridge's preclinical facility will meet western standards and comply with FDA Good Laboratory Practices and 21 CFR Part 11. More importantly, Bridge Preclinical Staff will have the skills and quality systems to maintain a validated facility. With the completion of the validation in Bridge's outstanding new showcase facility, we are confident that it will be at, or exceed, the quality levels of western standards."

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.