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MicroConstants, Inc.. (3/24/09). "Press Release: MicroConstants China Announces GLP-Compliance. MicroConstants Inc. Announces the USFDA and OECD GLP-Compliance of Its Beijing Bioanalytical Facility". Beijing.
|Organisation||MicroConstants China Inc.|
|Product||drug discovery services|
|Product 2||analytical services|
|Person||Yang, Q. David (MicroConstants 201011 CEO of MicroConstants China Inc)|
MicroConstants Inc., a Pharmacokinetic specialty Contract Research Organization (CRO) based in San Diego, California, announces today that its Beijing bioanalytical laboratory has met USFDA GLP requirements. MicroConstants China is offering DMPK and bioanalytical contract services to domestic and international pharmaceutical companies conducting preclinical and clinical studies in China. The establishment of the Beijing bioanalytical lab will eliminate the need for transferring valuable clinical samples across national borders.
MicroConstants set up its China operation (MicroConstants China Co. Ltd.) in June 2007 with the goal of providing the same high quality, USFDA GLP-compliant bioanalytical services in China to meet the growing demand of pharmaceutical outsourcing to Asia. After more than one year of vigorous cross-training, the QA supervisor of MicroConstants San Diego, Mary Mahoney, conducted a week-long thorough audit of MicroConstants China's operation.
"I am very impressed with our Beijing colleagues' progress over the last year", said Mary Mahoney of the MicroConstants China Beijing facility. "I found the quality systems there to be comparable to that of MicroConstants San Diego, and the MicroConstants China staff is certainly prepared to offer USFDA GLP-compliant bioanalytical and formulation analysis services."
Dr. David Yang, president of MicroConstants China Co. Ltd., is very pleased with the audit finding report. "Providing high quality service has been the goal of many preclinical and clinical CROs in China. We are very fortunate to be able to transfer MicroConstants San Diego's GLP quality systems to Beijing. Our employees are very motivated, and the lessons we learned during the last year will help us to implement GLP quality systems to our partners' sites in China."
Dr. Gilbert Lam, founder of MicroConstants Inc. in San Diego as well as MicroConstants China Co. Ltd., is very excited about the Beijing facility's progress. "This demonstrates that it is possible to transfer USFDA GLP-compliant programs from the U.S. to China. Our next task is to work with our partners in China to meet our clients' needs by providing one set of data that can be used for product registration in both China and abroad."
MicroConstants China Co. Ltd. is expecting its first client audit within the next month.
MicroConstants, Inc. is a privately held Contract Research Organization (CRO) that provides high quality DMPK and GLP bioanalytical services to the pharmaceutical and biotech industry. Established in 1998 in San Diego, MicroConstants, Inc. has provided discovery pharmacokinetics and GLP bioanalytical services to over 100 customers worldwide. In 2007, MicroConstants established its operation in Beijing, China to bring USFDA GLP-compliant bioanalytical services to those customers who are conducting preclinical and clinical PK studies in China. For more information about MicroConstants, please visit our website at http://www.microconstants.com.
For more information, contact:
+1 (866) 232-9497
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Record changed: 2016-03-20
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