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全球同一质量 · 一体化交付 | 方达控股(1521.HK)欧洲实验室扩建升级,进一步强化全球实验室检测能力

香港智远权证网2026年2月5日 00:00
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近日,美通社PR Newswire发布,方达控股位于意大利米兰的欧洲生物分析实验室完成整体搬迁与扩建升级,全新综合实验室面积约 2,500 平方米。新设施整合生物分析与中心实验室 功能模块,进一步提升样本处理能力、技术平台配置及跨区域协作效率,标志着方达控股在欧洲的临床支持能力迈入新的发展阶段。

依托全球一体化运营体系与国际统一质量标准,方达控股持续完善覆盖美中欧的生物分析与中心实验室网络,建立覆盖方法开发、验证、样本检测、数据管理、样本物流及项目管理的标准化流程。各区域实验室严格遵循 GLP/GCP 规范及 ICH M10 等国际指南要求开展工作,确保多中心研究间数据的一致性与可比性,为申办方推进多国注册申报及 MRCT 提供可靠保障。

从美国到中国,再到欧洲,方达控股始终坚持“One World, One System ”的服务理念,持续助力创新项目加速走向国际市场。升级后的欧洲实验室将进一步强化全球协同网络,与各区域平台深度联动,成为申办方推进国际临床开发与全球注册申报的可靠合作伙伴。

方达控股

方达控股是全方位的医药研发CRO公司,在中国、北美、欧洲分别建有生物分析中心,制剂产品开发中心,临床运营中心,药化中心,药理药效中心和非临床安评中心。为全球药企提供药物化学、药理药效、药学研究、DMPK、非临床安评、生物分析、综合实验室和临床研究等一站式研发外包服务。

方达控股始终坚守“全球同一质量体系”的准则,获得的试验数据支持多国申报。运营25年来,方达控股建立了经验丰富的科研团队和坚实的质量管理体系,累计通过NMPA和FDA等监管机构审计350余次,其中包括FDA审计超过200余次。

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