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GlobalSubmit™ REVIEW

Fast, simple, and easy eCTD reviews

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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)
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6
Number of global health authorities we support - FDA, EMA, Health Canada, Swissmedic, TGA (Australia), PMDA (Japan)
9
Submission types supported - IND, NDA, ANDA, sNDA, BLA, MAA, DMF, ASMF, NDS and more
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.

Travel a better road to submission

Create health authority compliant eCTD submissions quickly and accurately.

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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。

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利用 Pinnacle 21 临床数据管理和自动化套件提高临床试验申报数据的速度和质量。

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为什么选择 Certara

Certara leads the industry in regulatory science, providing cutting-edge tools and services that empower life sciences organizations to achieve their goals. With GlobalSubmit eCTD Software, you gain access to a best-in-class solution designed to simplify, accelerate, and enhance the submission process.

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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.

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Your data is safe with GlobalSubmit REVIEW

Certara’s eCTD software is ISO-certified, ensuring the highest standards of data security and compliance.

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


常见问题解答

What types of submissions does GlobalSubmit REVIEW support?

GlobalSubmit REVIEW supports IND, NDA, ANDA, sNDA, BLA, MAA, DMF, ASMF, NDS, and more.

Is GlobalSubmit REVIEW compliant with 21 CFR Part 11?

Yes, GlobalSubmit REVIEW is fully compliant with 21 CFR Part 11 regulations.

Can GlobalSubmit REVIEW integrate with my existing eDMS?

Absolutely, GlobalSubmit REVIEW seamlessly integrates with leading electronic document management systems (eDMS).

Is GlobalSubmit REVIEW cloud-based?

Yes, GlobalSubmit REVIEW is web-hosted, so no installation is required, and it is compatible with all operating systems and browsers.

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