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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 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. 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 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. 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

Confidence and compliance with your eCTD submissions

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.

  • 21 CFR Part 11 compliant
  • Validation provided for you with each release
  • Training provided by regulatory experts
  • Seamless integration with industry leading electronic document management systems (eDMS)
  • Supports investigational and marketing application submissions (IND, NDA, ANDA, sNDA, BLA, MAA, DMF, ASMF, NDS and more)
  • Compile eCTD submissions for various health authorities:
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