Home / GlobalSubmit eCTD Submission Software / GlobalSubmit™ REVIEW

GlobalSubmit™ REVIEW

Fast, simple, and easy eCTD reviews

适用于复杂监管环境的简化的 eCTD 申报文件审阅

GlobalSubmit REVIEW is a cutting-edge eCTD viewer designed to simplify and accelerate the regulatory submission review process. Regulatory professionals face immense challenges in ensuring timely and accurate eCTD submissions, often involving multiple stakeholders and complex approval workflows. GlobalSubmit REVIEW addresses these challenges by providing a streamlined, cloud-based platform that ensures compliance, reduces delays, and enhances collaboration. With its intuitive interface and robust capabilities, GlobalSubmit REVIEW empowers teams to confidently manage health authority-compliant eCTD submissions.

Streamline the eCTD review process, anytime and anywhere

GlobalSubmit REVIEW is purpose-built to meet the demands of a complex regulatory environment. By enabling seamless collaboration across stakeholders, this eCTD viewer ensures that your global submissions are reviewed efficiently and accurately. Whether managing investigational or marketing applications, GlobalSubmit REVIEW provides the tools needed to navigate the submission process with confidence.

Supports a wide range of submission types, including IND, NDA, sNDA, ANDA, BLA, MAA, DMF, ASMF, NDS and more
Fully compliant with 21 CFR Part 11 regulations
Seamless integration with leading electronic document management systems (eDMS)

联系我们

Number of global health authorities we support - FDA, EMA, Health Canada, Swissmedic, TGA (Australia), PMDA (Japan)

种申报类型支持包括 IND、NDA、ANDA、sNDA、BLA、MAA、DMF、ASMF、NDS 等

200

Error conditions utilized, including 40+ PDF checks

50%

Faster to load submissions, reducing wait time

Fast, simple, and easy eCTD reviews

Streamlined review process

GlobalSubmit REVIEW simplifies the eCTD review process by providing a user-friendly interface and advanced tools that reduce the risk of errors and delays.

Cloud-based accessibility

Access your eCTD submissions anytime, anywhere with a secure, cloud-based platform, reducing IT overhead.

监管合规性

Ensure compliance with health authority standards, including 21 CFR Part 11, with every submission.

申报之路畅通无阻

快速精准创建符合卫生监管部门要求的 eCTD 申报资料。

了解更多信息

利用人工智能生成的内容加快监管文件的创建速度，让撰稿人腾出时间进行关键分析、信息传递和完善。

了解更多信息

使用 Pinnacle 21® 临床数据管理与自动化套件，提升临床试验数据提交的速度与质量。

了解更多信息

为什么选择 Certara？

Certara 作为监管科学领域行业标杆，以尖端工具与服务赋能生命科学机构达成目标。通过 GlobalSubmit eCTD 软件，您将获得简化申报流程、加速进程并提升质量的一流解决方案。

联系我们

1.5m

The number of regulatory submissions managed with GlobalSubmit

网络研讨会点播

GlobalSubmit REVIEW and you: how to expedite the submission review process

Have you ever wondered how you could speed up the submission review process without compromising quality? Join us to learn more about the time-saving features of GlobalSubmit Review, such as Crosscheck, live validation, and more. We will explore these features as well as discuss how they can add efficiencies to your submission process.

点击观看网络研讨会

相关资源

查看全部

1 / 5

博客

成功递交 eCTD 的最佳做法

了解制药申办方在提交监管 eCTD 程序中遇到的常见陷阱以及解决这些问题的最佳实践。

查看详情

2 / 5

网络研讨会点播

RAPS 赞助的网络广播：糟了，出问题了！如何规避（与修正）监管申报常见错误

糟了，申报出错啦！无论是亲身经历还是旁观他人失误，此类疏漏往往令人尴尬讨论。本次网络研讨会将深度解析监管申报中高频出现的行政与技术性疏漏、数据差错及信息遗漏案例...

立即观看

3 / 5

白皮书

eCTD 提交流程：助力药物开发成功的技巧与诀窍

行业专家整合成功 eCTD 申报必备技巧与最佳实践指南。

查看详情

4 / 5

网络研讨会点播

GlobalSubmit eCTD 4.0 Webinars

电子通用技术文档（eCTD）v4.0 标准的发布将彻底改变全球电子监管申报领域。该最新版本包含更新的规范与指南，涵盖电子法规文档准备与提交全流程。

立即观看

5 / 5

博客

10 个关于 eCTD 4.0 的须知事项：迎接未来的监管提交

In this blog post, we explore the top 10 things you need to know about eCTD 4.0, and its potential benefits for the pharmaceutical industry.

查看详情

With GlobalSubmit REVIEW, your data is secure

Certara 信息安全管理体系（ISMS）已通过 ISO 27001 认证。我们已实施严密的安全控制措施，完成严格的风险评估，并持续改进。GlobalSubmit REVIEW ensures full compliance with global data protection standards, offering peace of mind for sensitive analysis.

Learn more in our Trust Center

预约演示

Discover how GlobalSubmit REVIEW can streamline your eCTD submission review process.

Simplify collaboration across stakeholders

Ensure compliance with health authority standards

Reduce delays and enhance submission accuracy

GlobalSubmit™ REVIEW

Fast, simple, and easy eCTD reviews

适用于复杂监管环境的简化的 eCTD 申报文件审阅

Streamline the eCTD review process, anytime and anywhere