Simplified eCTD submission review for a complex regulatory world

Let’s face it, reviewing your eCTD submissions is a cumbersome, and sometimes daunting task. If you’re like most regulatory professionals, you’re spending your time on meeting your organization’s goals on expediting its development to market by filing regulatory submissions as fast and as accurately as possible. Not to mention, avoiding major mistakes that push back submission dates and staying on budget.

We have often found that organizations have numerous stakeholders responsible for reviewing the content of their drug submissions. They are responsible for approving eCTD submission content quickly, fielding agency questions on the fly, and often require referencing in-stream as well as historical submissions to do so. The trouble is, without the right eCTD viewing software in place, simple yet critical review tasks can cause delays, increasing your risk of rejection, costs, and user frustration.

Certara’s GlobalSubmit WebReview and REVIEW were designed with these challenges in mind to help you facilitate the timely review of your eCTD submissions across your stakeholders.

 

GlobalSubmit WebReviewGlobalSubmit REVIEW
Ideal for most stakeholders across your organization needing to review specific content of your eCTD submissions.Ideal for publishers in your organization needing to do a granular review of your eCTD submissions and quality control (QC) of your hyperlinks and bookmarks.
Simplify your review process with an anywhere, anytime eCTD viewer

GlobalSubmit WebReview is a cloud-based eCTD viewer that facilitates an efficient and dynamic regulatory review of your electronic submission process through web-hosted access for all your global activities. Streamline your eCTD review process with innovative technology that:

  • Provides anytime, anywhere browser access with no IT installation required
  • Empowers your reviewers through an easy-to-use interface to quickly navigate and search through applications in seconds
  • Reduces your risk of costly errors and delays
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eCTD viewer designed for your stakeholders across various functional areas

GlobalSubmit WebReview was 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.). WebReview has been tested and validated with some of the largest applications received by Health Authorities and provides an impressive experience regardless of application size.

  • Usability – Friendly user interface (UI) combined with an intuitive user experience (UX) allows your reviewers to quickly navigate and search through applications
  • Speed – Dynamic opening of applications and large documents facilitates faster reviews
  • Scalability – Easily scalabe to accomdate larger audience reviews for peak times
  • Multiple views – View your application’s cumulative, sequence, current, and regulatory activities
  • Multiple formats – Complies with eCTD, NeeS, and RPS formats when implemented
  • Training – Provided by regulatory submission experts
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Reduce your QC process of eCTD submissions from hours to minutes

GlobalSubmit REVIEW provides your publishers with the tools they need to perform a granular review of your eCTD submissions.

Specifically, when it comes to the QC process of your eCTD submissions, independent tests show that the CROSSCHECK functionality in GlobalSubmit REVIEW is 8X faster and 3X more accurate when compared to traditional, manual methods of hyperlink and bookmark QC. This innovation expedites an activity that accounts for 40% of your working time when building your eCTD submissions.

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