GlobalSubmit™ REVIEW

适用于复杂监管环境的简化的 eCTD 申报文件审阅

我们必须承认，审阅 eCTD 申报文件是一项繁琐的，有时令人生畏的工作。If you’re like most regulatory professionals, you’re spending your time trying to meet your organization’s goals on expediting its development to market. This requires filing regulatory submissions as fast and as accurately as possible. 更别提避免会推迟申报日期的重大错误和保持预算了。

We have often found that organizations have numerous stakeholders responsible for reviewing the content of their submissions. 他们负责快速审批 eCTD 申报文件的内容、及时解决代理机构的问题，并且期间经常需要参考现有准备中的以及历来的申报文件内容。Without the right eCTD viewing software in place, simple yet critical review tasks cause delays, increase risk of rejection, and create additional costs.

GlobalSubmit REVIEW is designed with these challenges in mind. GlobalSubmit REVIEW enables you to facilitate timely reviews of eCTD submissions across stakeholders.

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Streamline the eCTD review process anytime and anywhere

GlobalSubmit REVIEW is designed to directly address the challenges of reviewing eCTD submissions in a complex regulatory world. GlobalSubmit REVIEW enables you to review health authority compliant eCTD submissions across stakeholders.

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Confidence and compliance with your eCTD submissions

对您 eCTD 申报的信心和合规性

GlobalSubmit REVIEW is built with ease-of-use in mind to facilitate a timely review across your various stakeholders responsible for approving specific content in your eCTD submissions (CMC, clinical, non-clinical, etc.). REVIEW has been tested and validated with some of the largest applications received by Health Authorities and provides an impressive experience regardless of application size. This cloud-based eCTD viewer offers unmatched capabilities giving you confidence in your submission.

Certara’s GlobalSubmit eCTD software has processed millions of regulatory submissions across a global footprint of health authorities.