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Company Overview

Development Stage

About the Company

上海瀚赛前身为美国NAMSA上海实验室,是迄今国内自2016年按照US FDA GLP体系运行至今的医疗器械行业。临床前动物实验室秉承科学、严谨和客观的宗旨,致力于成为遵从国际法规和标准,立足于中国医疗器械行业的一流临床前评价平台和专业教育中心。• 可靠的和一体化的GLP实验设施• 国内医疗器械CRO机构中,获得AAALAC(国际实验动物评估和认可委员会)认证• 国家设施认证、动物实验许可与环评批准• 团队/功能单元完整: 专题科研/质量保证/实验科学/IACUC/设施运营• 符合FDA GLP要求的标准操作程序(SOPs) & 质量管理体系(QMS)• 医疗器械监管机构的专业咨询顾问• 被监管机构认可的丰富经验:多个临床前安全性功效性研究通过了FDA PMA/510K及NMPA审核

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Business Registration

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Operating Status: 开业
Registered Capital: 3,020.8333万(元)
Legal Representative: 刘璞
Date Established:
Credit Code: 91310000MA1H39FA2Y
Registered Address: 中国(上海)自由贸易试验区临港新片区正琅路19号6幢

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