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Company Overview

Development Stage

About the Company

合肥锐晟医药科技有限公司成立于2022年,现有员工20余人。公司提供临床研究中心稽查、临床前药理毒理稽查、药物警戒稽查、TMF稽查、各类供应商稽查(PK/PD分析检测、中心实验室、PV、数据管理与统计、CRO、临床试验用药品管理供应商、中心影像评估等)等稽查服务以及国家局核查前模拟核查服务、药品注册核查支持服务、QA支持服务、注册咨询服务、临床研究中心调研评估服务、供应商选择调研评估服务、质量管理系统(QMS)咨询服务、培训服务等服务。公司自成立以来为60多家制药企业提供200多次稽查服务,80多项临床研究项目,涵盖30多个适应症。我们的理念不仅仅是发现问题,更要解决问题!以通过注册核查为主要目标的质量服务!部分骨干成员具有国家药监局食品药品审核查验中心(CFDI)职业药品检查员经验。目前公司稽查人员主要在北京、沈阳、厦门、南昌、合肥等地,可以为药物和医疗器械公司提供覆GCP/GLP/GCLP等多领域的质量管理(QA/QC)咨询服务。

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Business Registration

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Operating Status: 开业
Registered Capital: 200万(元)
Legal Representative: 包训杰
Date Established:
Credit Code: 91340103MA8NN5APXY
Registered Address: 安徽省合肥市高新区创新大道2688号中新网安大厦1306

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“医药研发临床研究服务商”

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