摘要：5月20日，上海美迪西生物医药股份有限公司（以下简称“美迪西”）全资子公司美迪西普亚医药科技（上海）有限公司（以下简称“美迪西普亚”）收到美国食品药品监督管理局（FDA）正式函件和现场检查报告（EIR），报告显示美迪西顺利通过了FDA的检查。这一里程碑式的成就
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5月20日，上海美迪西生物医药股份有限公司（以下简称“美迪西”）全资子公司美迪西普亚医药科技（上海）有限公司（以下简称“美迪西普亚”）收到美国食品药品监督管理局（FDA）正式函件和现场检查报告（EIR），报告显示美迪西顺利通过了FDA的检查。这一里程碑式的成就，不仅再次印证了美迪西作为一站式生物医药临床前研发服务平台的的卓越能力和严苛标准，更彰显了专业实力与国际影响力。
通过FDA审查，源于坚守质量至上
在审查期间，FDA审查官对美迪西普亚的组织机构与管理、人员资质、标准操作规程（SOP）、实验设施、档案文件、实验实施过程、质量保证体系以及计算机化系统等多个方面进行了全面而细致的检查。此外，FDA审查官还重点溯源检查了多个申报FDA的研究专题。
对于美迪西普亚所展现的高效率、严谨的科学精神，FDA审查官给予了高度的评价和积极的反馈。他们期待未来能继续接收到美迪西普亚提交的高质量研究数据。这次复查的优异表现，是对美迪西长期坚守“质量至上”原则的最好诠释。
时隔七年再度顺利通过FDA的现场检查，不仅为美迪西在FDA的合规记录上增添了宝贵的信誉分值，更是对美迪西长期以来坚守“创新驱动，质量至上”的全面肯定与高度赞誉。展望未来，美迪西将矢志不渝地加大技术创新与研发投入，致力于推出更加创新、更加完善的技术与服务解决方案，拥抱全球医药市场的广阔机遇与挑战，助力全球生物医药产业的发展！
关于美迪西
美迪西（股票代码：688202.SH）成立于2004年，总部位于上海，致力于为全球制药企业、研究机构及科研工作者提供全方位的临床前新药研究服务。美迪西的一站式综合服务以强有力的项目管理和更高效、高性价比的研发服务助力客户加速新药研发进程，服务涵盖医药临床前新药研究的全过程，包括药物发现、药学研究及临床前研究。至2024年，美迪西已为全球超2000家客户提供药物研发服务，参与研发完成的新药及仿制药项目已有520件IND获批临床，与国内外优质客户共同成长。美迪西将继续立足全球视野，聚力中国创新，为人类健康贡献力量！
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On May 20, Medicilon Preclinical Research (Shanghai) LLC ("Medicilon") received an official letter and Establishment Inspection Report (EIR) from the FDA. The report indicates that Medicilon has successfully passed the FDA inspection. This milestone achievement not only reaffirms Medicilon's excellence as a one-stop preclinical R&D service platform but also highlights its professional expertise and global influence.FDA Inspection Success: A Commitment to Quality
During the inspection, FDA auditors conducted a comprehensive review of Medicilon's organizational structure, personnel qualifications, SOPs, facilities, documentation, experimental processes, quality assurance systems, and computerized systems. Additionally, the auditors traced and reviewed multiple research projects submitted to the FDA.The FDA inspectors highly praised Medicilon for its efficiency and rigorous scientific approach, expressing their anticipation for receiving more high-quality research data in the future. This successful inspection is the best interpretation to Medicilon's long-standing commitment to "Quality First."Passing the FDA on-site inspection after seven years not only adds valuable credibility to Medicilon's FDA compliance record but also serves as a strong endorsement of the company's commitment to "Innovation Driven, Quality Focused." Looking ahead, Medicilon will continue investing in R&D to deliver innovative solutions and contribute to the global pharmaceutical industry.About Medicilon
From its inception in 2004, Shanghai Medicilon Inc. (stock code: 688202.SH) has been committed to providing comprehensive R&D services to pharmaceutical companies, research institutions, and any organizations working in the preclinical space. By the end of 2024, Medicilon has provided drug development services to over 2,000 clients worldwide, and has been involved in the research and development of 520 new drugs and generic drug projects that have been approved for clinical trials with IND applications.
来源：动态宝