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喜报 | 再创“零缺陷”辉煌!方达控股中国实验室近1年内连续三次零缺陷通过FDA现场核查

香港智远权证网2026年2月5日 00:00
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2026年2月2日-2月5日,美国食品药品监督管理局(FDA)对方达控股中国区小分子生物分析平台进行了为期四天的飞行检查。面对又一次“不打招呼”的国际质检大考,实验室团队凭借深厚的合规底蕴与成熟的管理体系,从容、专业、高效地完成了全程核查。

此次检查覆盖质量体系、数据完整性、项目执行与人员资质等核心环节。最终,实验室再次以“零缺陷”的优异结果圆满通过审查,这不仅是对我们长期坚持的最高质量标准的再次确认,也充分证明了方达控股中国实验室的质量管理始终持续处于稳定、可靠的卓越阶段。

三战三捷,铸就质量金标准

2025年5月,苏州小分子生物分析实验室,零缺陷通过FDA飞行核查

2025年5月,上海大分子生物分析实验室,零缺陷通过FDA飞行检查

2026年2月,上海小分子生物分析实验室,零缺陷通过FDA飞行检查

连续两年、三大核心生物分析实验室均以最高标准通过全球最严苛药监机构的突击审查,这不仅是对我们“全球同一质量体系”的反复验证,更是方达控股“质量为先”核心价值观的生动体现。从容应对到结果满意,背后是每一天对合规的坚守、对细节的执着。

作为具备中美两地完整服务能力的研发平台,方达控股持续深化中美一体化运营与质量体系建设,为合作伙伴提供“中美双报”的高效路径,显著缩短研发周期,降低合规风险,助力中国创新药企及生物科技公司顺利走向国际市场。

方达控股始终以值得信赖的数据和专业服务,为全球合作伙伴的创新药研发与申报保驾护航。以中国智慧与国际标准深度融合,助力中国智造,赋能全球健康!

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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