United States of America (Press Release) March 25, 2009 -- 03/25/2009; MicroConstants Inc., a DMPK and bioanalytical specialty Contract Research Organization (CRO) based in San Diego, California, announces today that its Beijing bioanalytical laboratory has met FDA GLP requirements.
MicroConstants set up its China operation (MicroConstants China Co. Ltd.) in June 2007. 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 from March 2nd-6th, 2009.
“I am very impressed with our Beijing colleagues’ progress over the last year”, said Mary Mahoney. “I found the quality systems there are comparable to that of MicroConstants San Diego and the MicroConstants China staffs are certainly ready to offer FDA GLP compliant bioanalytical and formulation analysis services.”
Dr. David Yang, President of MicroConstants China Co. Ltd., is very pleased with the audit finding report. “We are very fortunate to be able to transfer MicroConstants Inc. GLP quality systems to Beijing. Our employees are very motivated and the lessons we learned during the last year will help us implement GLP quality systems to our partners’ sites in China.”
Dr. Gilbert Lam, founder of MicroConstants Inc. in San Diego and MicroConstants China Co. Ltd., is very excited about the Beijing facility’s progress. “The establishment of the Beijing bioanalytical lab will eliminate the need for transferring valuable clinical samples across national borders. 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.
About MicroConstants Inc. and MicroConstants China Co. Ltd.
MicroConstants, Inc. is a privately held contract research organization providing 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 U.S. GLP compliance bioanalytical services to those customers who are conducting preclinical and clinical PK studies in China.