HIPPOCRATES

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辛格迪:生命健康质量合规专家

“辛格迪” 源自古希腊医学之父(Hippocrates)音译。深耕行业二十余年,公司以 GMP 合规咨询为起点,成长为国内领先的医药数字化解决方案供应商。我们参与国家级 GxP 数字化标准编制,兼具咨询与数字化研发实力,依托全球药监资源,产品符合 GxP 规范,适配FDA、EMA、WHO等海内外监管要求。自研QMS、DMS、TMS 质量合规套件稳居国内第一梯队,其他产品还包括 VDR、eSIGN、PVS、EBR、WMS、CGT、eMAH等,支持集团及全球化部署,兼具提供合规管控、数据治理、CSV 验证一站式服务。辛格迪的客户包含恒瑞医药、上海医药、丽珠医药、长春金赛、华润医药、义岭药业等国内头部药企,科济药业、凯莱英、义翘神州等生物科技标杆企业,以及罗氏、小林制药、GSK 等跨国药企。现已助力上百家企业实现审计零缺陷,赋能药企数字化转型、降本增效与全球化发展。
                                               

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产品

GMP文件管理系统 (DMS)

GMP培训管理系统 (TMS)

GMP质量管理系统 (QMS)

虚拟数据室管理系统 (VDR)

电子合约管理系统 (e-Sign)

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解决方案

委托生产质量管理协同方案

数字化工厂解决方案

细胞治疗生产与追溯方案

临床研究解决方案

药物警戒解决方案

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服务

CSV验证咨询

GMP合规咨询

MAH咨询服务

GxP培训定制

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客户信赖

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