监管解决方案

监管信息管理 (RIM)

“品质绝非偶然,它始终是明智努力的硕果。”
——约翰·拉斯金

让监管提交不再困扰您

With nearly 20 years of experience in regulatory compliance, Calyx's industry-leading Regulatory Information Management (RIM) system will help ensure you meet regulatory requirements worldwide.

从复杂到合规的过程

监管提交可能很复杂、耗时并且面临不合规的可能性。无需担心您的监管提交,专注于将新的医疗解决方案推向市场。

凯理斯 RIM 可通过以下方式推动监管合规:

– 简化并优化您的监管事务流程
– 建立全面的注册监督
– 提供从单一位置追踪您在世界各地的注册情况

我们是怎样做的?通过提交规划、出版和注册管理功能,凯理斯 RIM 可在监管过程的各个阶段为您提供支持。

您可以信赖的经验

在世界排名前 20 的全球制药公司中,有 18 家依赖凯理斯的 RIM 软件。

联系我们,以了解凯理斯的丰富经验和经验证的 RIM 系统如何能够为您项目的成功铺平道路。

了解凯理斯 RIM 如何助推您的监管提交取得成功。

凯理斯 = 解决提交问题

成功的监管提交需要的不仅仅是新技术。与一家不仅了解监管复杂性,而且还能将最佳配套系统整合起来,以满足利益相关者需求的供应商合作至关重要。

凯理斯是监管信息管理领域的先驱。Since the early 2000’s, over 20 million regulatory records have been seamlessly migrated into the Calyx RIM system, representing over 1 million global submissions to date.

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The future of Calyx RIM is on Azure

Leverage the latest Azure-native technologies designed to improve regulatory efficiencies while ensuring patient safety.

Calyx RIM on Azure gives you the flexibility to choose the timing of your upgrade to ensure minimal system disruption. Through automated components and cutting-edge microservices, rapid upgrades are delivered directly  ̶  at a time that suits your business needs and schedule  ̶  so you gain access to new features while maintaining compliance with global regulatory requirements.

Benefits of Calyx RIM on Azure

– Accelerated return on investment through resource savings

– Optimized workflows to drive regulatory efficiencies

– Shortened release cycles

– Immediate availability of new capabilities

– The elimination of lengthy and expensive software upgrades

Your source for IDMP readiness

With the deadline for IDMP submissions on the horizon, it’s time to regroup and ensure your data is ready for submission. Will you be ready?

To help you prepare, we’ve amassed a variety of resources including articles, updates, and guides detailing how to overcome implementation challenges and what factors need to be considered to ensure your compliance with IDMP Iteration 1 submissions.

文库

The MAH’s Guide to Preparing for IDMP

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基于 Azure 的凯理斯 RIM

了解基于 Azure 的凯理斯 RIM 如何将微软公司的可扩展、灵活和安全平台的性能和功能与凯理斯的专业知识相结合。
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优化监管信息管理

凭借有效的监管信息管理 (RIM) 系统,您可以吸取经验教训、预测监管要求并最终使医疗解决方案更快获得批准,从而帮助改善人类的生活。
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使用适用于 Office 365 的凯理斯 RIM 来改变您的工作方式

探索适用于 Office 365 的凯理斯 RIM 如何通过利用机器学习简化日常工作来提高工作效率。
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