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        2. 公司介紹


          蘇州華測生物技術有限公司(以下簡稱:華測生物)是一家專業從事新藥臨床前研究技術外包服務的企業,由華測檢測認 證集團股份有限公司(股票代碼:300012)于2011年在蘇州昆山投資成立。目前華測生物已發展成為設施先進、技術一流、 實力雄厚的專業化藥物安全性評價中心。公司已通過的權威認證有:國家食品藥品監督管理總局(NMPA)的藥物GLP認證 (2016年2月)。中國合格評定國家認可委員會(CNAS)的實驗室認可證書(2017年9月)。國際AAALAC完全認證(2017年11 月)。公司嚴格遵循NMPA和FDA等的GLP規范,致力于為國內外生物醫藥企業、科研機構等客戶提供安全性評價、藥代/毒 代動力學生物分析測試及藥效學等“一站式”技術服務。

          華測生物天然具有區位優勢:位于昆山高新區,毗鄰蘇州工業園區,東倚創新藥物基地上海,處于長三角生物醫藥產業集 群的核心位置。華測生物占地72畝,一期工程建有符合國際GLP標準的實驗室13,300多平方米。公司擁有卓越的人才隊伍: NMPA新藥評審專家3人,GLP檢查專家2人。核心技術團隊150余人,其中高級職稱6人,本科及以上學歷超過60%,教育 背景涵蓋醫學、藥理學、毒理學、動物醫學、生物學等。

          CTI Biotechnology (Suzhou) Co., Ltd.(hereinafter referred as CTI BIO) is a CRO company specializing in the preclinical research for new drugs,invested by Centre Testing International Corporation (Stock Code: 300012) in 2011 in Kunshan Suzhou. Now CTI BIO is a professional drug safety evaluation center with advanced facilities, first -class technology and strong technical strength.Authorized certificates:China Food & Drug Adminstration official GLP certificate (February 2016).The laboratory accreditation certificate ofChina National Accreditation Commit -tee for conformity assessment (CNAS) (September 2017).AAALAC International full accreditation (November 2017). We are committed to providing one-stop technical service, such as safety evaluation, pharmacokinetic/toxicokinetic bioanalysis and pharmacodynamics, for customers of domestic and oversea biomedical enterprises and scientific research institutions.

          CTI BIO has geographical advantages by nature: located in Kunshan New & High-Tech Development Zone, adjacent to Suzhou Industrial Park Zone, with new drug innovation base Shanghai in east, enjoying the geographical advantage in the core position of Yangtze River Delta medicine industrial cluster.CTI BIO occupies 72 mu, and the facility of Phase I project covers 13,300 square meters with laboratories in comply with international GLP standards. CTI BIO has an excellent talent team: 3 NMPA new drug reviewers and 2 GLP investigators. The core technology team is consist of more than 150 people, including 6 members with senior professional titles, and over 60% with bachelor’s degree or above, with education background in medicine, pharmacology, toxicology, animal medicine, biology, etc..

          • 藥代動力學研究

          • 安全性研究評價

          • 藥效學研究