BEIJING, CHINA, November 5, 2010 - MicroConstants China Inc., a Contract Research Organization (CRO) specializing in preclinical and clinical pharmacokinetics contract research, announces the accreditation of its bioanalytical laboratory by the China National Accreditation Service for Conformity Assessment (CNAS), a Chinese government agency that monitors quality systems of analytical laboratories based on ISO-17025 guidelines.
Independent bioanalytical CROs represent a new business model in China and the China State Food and Drug Administration (SFDA) has not yet implemented any regulations on its operation. Although MicroConstants China has adopted USFDA, OECD and MHLW Good Laboratory Practices (GLP) in its bioanalytical laboratory in Beijing, China, many domestic customers are unfamiliar with these quality systems.
“The accreditation by CNAS will not only allow us to further penetrate into the China market, but it also gives us the status of third party independent analytical lab,” says Dr. Q. David Yang, chief executive officer of MicroConstants China. “We’re very excited about this accreditation because it presents us with the opportunity to enter into analytical-related service areas in addition to pharmaceutical analysis, such as food and cosmetic safety.”
CNAS auditors were onsite in July of 2010 for a two-day audit of the Beijing laboratory and were very impressed with MicroConstants China’s GLP-compliant quality program. Following the visit, the auditors recommended that MicroConstants China be fully certified.
“CNAS accreditation has demonstrated that our Chinese colleagues can conduct the same kind of quality work as our employees in San Diego,” said Dr. Gilbert Lam, president of MicroConstants China and founder of MicroConstants, Inc. of San Diego, California. “We are very proud of their progress and believe this is a step in the right direction towards receiving quality system validation and accreditation from other government agencies.”
About MicroConstants China Inc.
MicroConstants China Inc. is a Contract Research Organization (CRO) that was established in 2007 by the founder and president of MicroConstants, Inc., a bioanalytical and pharmacokinetic specialty CRO in San Diego, California, USA with over a decade of GLP compliance history. Located in Beijing, China, MicroConstants China provides premier quality preclinical and clinical pharmacokinetic analysis services to pharmaceutical and biotech companies worldwide. Its bioanalytical laboratory is fully GLP-compliant with USFDA, OECD and MHLW guidelines. MicroConstants China also offers early stage clinical trial management, quality system consulting and project management services for preclinical toxicology and pharmacology studies in China. For more information about MicroConstants and the contract research services they provide, please visit http://www.microconstants.com.
For more information, please contact:
MicroConstants China Inc.
+86 (10) 5257 3257