Press Releases

FDA Renews Licenses for Synchrogenix’s GlobalSubmit Software to Review and Validate New Drug and Biologics Applications

Sep 25, 2019, 08:11 AM by Michael Croft
PRINCETON, NJ - Sep 25, 2019 - Certara®, the global model-informed drug development and decision support leader, today announced that the US Food and Drug Administration (FDA) has renewed its legacy licenses for Synchrogenix’s electronic Common Technical Document (eCTD) review software, GlobalSubmit REVIEW™ and GlobalSubmit VALIDATE™ for another year

PRINCETON, NJ - Sep 25, 2019 - Certara®, the global model-informed drug development and decision support leader, today announced that the US Food and Drug Administration (FDA) has renewed its legacy licenses for Synchrogenix’s electronic Common Technical Document (eCTD) review software, GlobalSubmit REVIEW™ and GlobalSubmit VALIDATE™ for another year. FDA has been using this GlobalSubmit software consistently since 2005.

 

These licenses provide enterprise-wide use of the GlobalSubmit software for more than 6,000 users at FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) divisions for reviewing new drug and biologics applications. Synchrogenix is Certara’s regulatory science division.

 

“We are excited to continue our longstanding partnership with FDA and share news of its legacy license renewal,” said Justin Edge, president of Synchrogenix. “Leading with innovation, we have continued to develop new products that build upon our existing domain expertise to simplify the preparation and review of new drug and biologics applications. For example, our new eCTD review software, GlobalSubmit WebReview, is a simple, secure, browser-based solution with anytime, anywhere access.”

 

Synchrogenix developed GlobalSubmit WebReview to enhance the efficiency and user experience when submitting and reviewing regulatory documents. GlobalSubmit WebReview provides cloud-powered, web-hosted access to the many regulatory activities within the submission, without the need to install software. Able to handle larger applications and documents in a smarter way, this new software can open documents with thousands of sequences in just seconds. As a result, it accelerates the review process while maintaining strict quality standards.

 

GlobalSubmit REVIEW facilitates the regulatory review process by providing both the sponsor and FDA with an identical vantage point, ensuring that each regulatory activity can be filed and viewed according to regulations. GlobalSubmit VALIDATE is used exclusively by FDA to assess the technical validation criteria of all eCTD submissions passing through its Electronic Submissions Gateway, confirming compliance standards are met.

 

About Certara

Certara optimizes R&D productivity, commercial value and patient outcomes through its unique portfolio of model-informed drug development, regulatory science, and market access solutions. In fact, 90+% of all novel drugs approved by the US FDA in the past four years were supported by Certara software or services. Its clients include 1,600 global biopharmaceutical companies, leading academic institutions, and key regulatory agencies across 60 countries. For more information, visit www.certara.com.