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迈康斯德北京实验室第四次顺利通过OECD现场核查

2018-10-30 09:31:19

迈康斯德北京实验室第四次顺利通过OECD现场核查

 

中国北京,2018年5月28日

 

迈康斯德其位于北京经济技术开发区的GLP药物代谢动力学生物分析实验室再次顺利通过经济合作与发展组织(OECD)现场核查。本次现场核查,从2018年3月21至23日,历时三天,这是迈康斯德北京实验室第四次通过OECD核查。

 

迈康斯德实验室在2011年成为国内首家获得OECD GLP认证的药代动力学生物分析实验室,此后一直坚守国际质量标准,为客户提供可靠的数据。实验室擅长用液质联动和酶联免疫等手段开发和验证各种小分子和大分子药物的分析方法,并按照CFDA,美国FDA,欧盟EMA及其他国家药物监管机构相关法规和指导原则开展方法学验证、临床前和临床药物代谢动力学样品的生物分析工作。  

 

关于迈康斯德:

迈康斯德是一家国际化的合同服务组织(CRO)。公司以北京为中心,分别在广州、上海、美国等地设立了分支机构,按照FDA,ICH GCP, OECD GLP等国际标准,为国内外医药企业和生物技术公司提供可同时用于国内外申报的新药临床试验、仿制药生物等效临床试验、和PK样品生物分析一站式技术服务。 

 

联系方式:

 

网站:www.microconstants.com.cn

地址:北京经济技术开发区科创十四街99号18号楼一单元二层

邮编:101111

邮箱:info@microconstants.com.cn

联系人:孙睿 18616027613

 

 

 

 

MicroConstants China's GLP Facility Passed OECD GLP Inspection

 

BEIJING, May 28, 2018

 

MicroConstants China Inc., a Contract Research Organization (CRO) conducting preclinical pharmacokinetics studies and providing full-service clinical trial management in Beijing, announces the reissurance of Endorsement of Compliance with the OECD Principles of Good Laboratory Practice (GLP) in the areas of analytical chemistry and pharmacokinetic studies from the Health Care Inspectorate, Ministry of Health, Welfare and Sport of Netherlands.

 

MicroConstants China is the first test facility in China to receive the Endorsement of OECD GLP Compliance in the area of Pharmacokinetics Studies. It first received Endorsement on May 23, 2011.On March 21-23, 2018, the Netherlands GLP inspectors conducted the fourth time renew endorsement inspection. We were informed we passed the inspection today.

 

"The continued OECD GLP Endorsement, exemplify our pursuit of conducting highquality contract research services to meet the global regulatory requirement. "Said Dr. Q. David Yang, CEO of MicroConstants China. "We will continue to expand our service scope and capability to meet our clients' demand." 

 

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 PK specialty CRO in San Diego, California with over a decade of GLP compliance history. MicroConstants China provides preclinical and clinical pharmacokinetic analysis and clinical trial management services, including clinical site qualification, trial monitoring, data management, biostatistics, and clinical summary reports to pharmaceutical and biotech companies worldwide. Additionally, the CRO offers QA audit and drug development project management services for preclinical toxicology studies in China. Its bioanalytical laboratory is fully GLP-compliant with USFDA, OECD, Japan MHLW and China CFDA guidelines. For more information about MicroConstants China and the contract research services they provide, please visit http://www.microconstants.com.cn.

 

Contact info.

info@microconstants.com.cn

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