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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)

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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。

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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 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。

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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 eCTD 软件通过 ISO 认证，确保数据安全与合规性遵循最高标准。

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