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IND申报支持服务
IND 申报支持

为您项目的每个阶段提供正
确的解决方案

IND申报支持服务

以合适的规模为您 IND 申报项目的每个阶段提供准确的服务和正确的解决方案。

新药 (IND) 项目的设计、执行和申报是一项艰巨的任务,需要对多个试验项目进行广泛的规划和持续的协调,每个学科相互关联,以完成连续的项目研究。在方达医药,我们通过提供所有关键的 IND 申报支持服务,可以简化工作并降低风险。一体化组织的规模可最大限度地降低复杂性并最大限度地提高沟通效率,使您的主要候选化合物进入临床1期阶段。

无论您是小型初创企业还是大型制药企业,我们都将用专业知识和能力来为您定制项目,以将您的 IND 申报项目顺利推进完成。

准确的服务

在方达医药,我们提供全套的新药研发服务,从候选化合物筛选过渡到首次人体试验。通过提供准确的全面无缝衔接的服务,我们可以加速您的IND申报计划。与方达医药合作,您会收获始终如一的质量、更高的效率和最佳的跨职能沟通,即我们的一体化服务。

IND 项目管理 1 - IND 支持服务

我们的 IND申报 服务范围包括

  • 原料药合成
  • 制剂开发
  • 药物代谢和动力学研究,
    药物安全性评价
  • 生物分析
  • 化学生产和控制 (CMC)
  • Non-GLP/GLP/GMP批量生产
  • 临床I期方案设计

合适的规模

在方达,我们相信有效的沟通是我们一切成功的基础,并且作为一家 中型CRO,我们的规模合适,可确保我们始终专注于客户及其需求。无论是在内部还是与我们的客户进行及时、一致和清晰的沟通,这对于确保取得成功至关重要。

正确的解决方案

我们了解到每个客户都有独特和特定的需求。 方达团队由有资质的项目经理、专题负责人和研究人员组成,协同工作,倾听您的意见并确保您的期望得到充分理解。

我们的一体化 IND 申报支持服务,加上我们合适的规模,能确保响应的及时性,这可能比通常的 IND 申报项目的时间表要加快几个月。这就是拥有准确服务和合适规模的全部意义所在。

无论您的项目规模如何,我们专注的项目负责人都将与您的团队密切合作,以确保您的项目得到应有的关注和支持。

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