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    RFI

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    A specialist working at a computer, managing a multi-phase pharmaceutical project, focusing on cost optimization, schedule planning, and regulatory compliance.

    项目管理

    有效管理多阶段制药项目对于其成功实施至关重要,特别是在涉及多个合作伙伴/承包商的情况下。我们提供计划项目实施所需的各种活动的机会,包括成本和进度优化。我们还可以组织和管理整个过程,以确保所有任务都能及时、正确地执行。由于需要跟上全球和当地市场的快速注册变化,并及时了解GxP要求,如果需要修改原始项目设计,我们能够做出适当的反应。

    SciencePharma提供的典型服务:

    • 根据当前的指导方针、建议和我们的经验制定注册战略,
    • 研发研究的管理,包括:
      • 从概念到实验室、中试和最终规模的分析和技术开发,全面规划和组织研发研究(包括设计原则的质量),
      • 制定活性物质和药品的质量标准,尽量减少分析成本,
      • 分析设计和评估,
      • 稳定性研究的成本效益设计,
      • 评估制造工艺及其优化(如有必要),
      • 审查生产流程并就制造战略提出建议,
      • 支持分析和技术故障排除,
      • 验证协议的设计,
      • 非临床和临床研究的设计和组织,
    • 制定产品开发计划,说明可能的情况、关键阶段和必要的资源,
    • 制定项目进度表和初步预算,
    • 管理研发项目,协调实验室和分包商。

    我们以在规划、组织和管理复杂制药项目方面的经验而闻名,我们为我们的成功感到自豪。我们的专家可以帮助研究将医疗产品投放市场的最短路线和时间框架,并在以后支持产品的生命周期管理。

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      请注意,在上述表格中输入的个人数据的管理员是SciencePharma Sp. z o.o. 注册办事处位于Warsaw, Chełmska 30/34. 处理这些数据是为了接收收到的信件并对其作出回应。提供个人数据是自愿的,但对于发送表格是必要的。每个人都有权访问他们的数据并对其进行更正。

      您可以查看有关个人数据保护的详细信息点击这里.