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Bridge Successfully Validates Beijing Preclinical Laboratory for US Level GLP Compliance.


SAN FRANCISCO San Francisco (săn frănsĭs`kō), city (1990 pop. 723,959), coextensive with San Francisco co., W Calif., on the tip of a peninsula between the Pacific Ocean and San Francisco Bay, which are connected by the strait known as the Golden  -- Bridge Pharmaceuticals:

--Bridge, with the assistance of B-W Design Group and Instem, has successfully validated the first phase of instrumentation, HVAC/BMS Systems and its Provantis data acquisition software for full FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
 Part 11 Compliance

Bridge Pharmaceuticals, 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 BMS
abbr.
Bachelor of Marine Science
 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 See gateway location protocol.  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 B-W Design Group and Instem's Provantis validation team," commented Dr. Ada Kung Ph.D., DABT DABT Diplomate of the American Board of Toxicology , EVP EVP Executive Vice President
EVP EGR (Exhaust Gas Recirculation) Valve Position Sensor
EVP Electronic Voice Phenomenon
EVP Europäische Volkspartei (Germany)
EVP Employee Value Proposition
 and CTO (Chief Technical Officer) The executive responsible for the technical direction of an organization. See CIO and salary survey.  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 regulatory agency

Independent government commission charged by the legislature with setting and enforcing standards for specific industries in the private sector. The concept was invented by the U.S.
 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 (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board.  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 B-W 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 CFR

See: Cost and Freight
 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 Bridge Pharmaceuticals

Bridge Pharmaceuticals is a US-headquartered company focused on providing cost effective, FDA compliant drug development services in Asia for US, EU and Asian based clients. Bridge is a spin off of SRI International (Menlo Park, CA). Bridge's Beijing preclinical laboratory is the first and only US level GLP and AAALAC AAALAC Association for Assessment and Accreditation of Laboratory Animal Care (formerly American Association for the Accreditation of Laboratory Animal Care)  designed facility in China. Bridge provides complete end-to-end drug development expertise including US IND submissions. The Beijing facility provides services for FDA compliant GLP toxicology, pharmacology, predictive PK/ADMET, safety pharmacology, formulation and other services. Through its Vital Bridge joint venture, Bridge accesses animal supplies from the largest and only US-franchised quality animal breeding facilities in China. For more information, visit www.BridgePharmaceuticals.com or call (650) 859-3853.

Instem is a world-leading information solutions provider for the Life Sciences -- accelerating drug and chemical development by increasing client productivity and enhancing the processes that lead to safer, more effective products. For more information on Instem and its solutions, please visit www.instem-lss.com or contact them by email at info@instem-lss.com.

B-W Design Group is a leading supplier of Validation and Regulatory Services, Manufacturing Automation, Business Intelligence, and Process Instrumentation and Controls (PCS (1) (Personal Communications Services) Refers to wireless services that emerged after the U.S. government auctioned commercial licenses in 1994 and 1995. This radio spectrum in the 1. ) to the Life Sciences Industries. Since 1986, Design Group has provided project leadership, technical insight and extensive professional resources to leading Pharma and Biotech companies. For more information, visit www.bwdesigngroup.com, by email at Howard.Treadaway@bwdesigngroup.com or call (925) 242-1070.

Copyright (C) 2006, Bridge Pharmaceuticals, Inc. All rights reserved.
COPYRIGHT 2006 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2006, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Date:Sep 6, 2006
Words:665
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