FDA awards Synchrogenix contract extension for eCTD Management Software

By on Wednesday, July 19, 2017 in Industry Updates

On June 15th, the United States Food and Drug Administration (US FDA) awarded Synchrogenix a contract extension for the electronic common technical document (eCTD) submission management software: GlobalSubmit REVIEW™ & GlobalSubmit VALIDATE™ This contract extension provides a continuity in the drug review process and marks the 12th anniversary of the exclusive...

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FDA upgrades eCTD environment

By on Wednesday, July 19, 2017 in Industry Updates

FDA upgrades eCTD environment to newest version of GlobalSubmit VALIDATE The US Food and Drug Administration (US FDA) has upgraded their GlobalSubmit VALIDATE™ suite as of July 10th, 2017 implementing the new eCTD validation criteria for Study Data Technical Conformance. This upgrade focuses on new eCTD validation changes, including new High Level validation errors...

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Overview MANAGE Regulatory Status

By on Thursday, February 2, 2017 in GlobalSubmit RIM

This video provides a brief overview of the Regulatory Status module which is part of GlobalSubmit’s MANAGE product. The information managed in this module will provide your organization with real-time reporting on the current status of global regulatory...

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Three and a Half Million Application Pages Submitted by GlobalSubmit Regulatory Services Over 30-Day Strech

By on Thursday, December 22, 2016 in Press Releases

Philadelphia, PA – December 22, 2016 Over a 30-day stretch in Q4 2016, GlobalSubmit’s Regulatory Services team submitted an impressive 3.5 million application pages. Included in that total were 2 New Drug Applications (NDAs) submitted to the US FDA, one of which was submitted as a 505(b)(2). Each NDA represents the first marketing application filed for each...

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PDFs not Displaying in REVIEW

By on Wednesday, December 7, 2016 in Customer Support CBT

GlobalSubmit’s eCTD Submissions Management Suite is designed to publish and review “submission ready” PDF documents. A non-functioning Preview Pane can limit your productivity in the system. Here are a few troubleshooting resolutions you can try to correct the issue of the Preview Pane not displaying as expected....

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GlobalSubmit 2016 (v10.0) Available to Industry

By on Monday, August 22, 2016 in Press Releases

Enhancements Focus on System Performance, Regional Updates Philadelphia, PA – August 22, 2016 GlobalSubmit Inc., (www.globalsubmit.com) an industry leader in technology solutions and professional services to support regulated product submissions, announces that GlobalSubmit’s Submission Management Suite 2016 R1 (v10.0) is now available to industry in a variety of...

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GlobalSubmit to Exhibit at 2015 RAPS in Baltimore

By on Thursday, October 15, 2015 in Press Releases

GlobalSubmit Inc., (www.globalsubmit.com) an industry leader in technology solutions and professional services to support regulatory submissions, will exhibit at the upcoming RAPS Regulatory Convergence in Baltimore, MD October 24-28. GlobalSubmit is located at booth #113 in the Baltimore Convention Center. While RAPS is a unique opportunity to showcase...

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GlobalSubmit Names Evan Richardson Director of Regulatory Services

By on Monday, June 15, 2015 in Press Releases

GlobalSubmit Inc., (www.globalsubmit.com) an industry leader in technology solutions and professional services to support regulated product submissions, would like to introduce Evan Richardson, Director of Regulatory Services, as the newest member of our Management team. “For the majority of my career, I’ve been a GlobalSubmit client and an outspoken...

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GlobalSubmit 2015 Available to Industry; Adds Productivity, User Experience Enhancements

By on Monday, June 1, 2015 in Press Releases

GlobalSubmit Inc., (www.globalsubmit.com) an industry leader in technology solutions and professional services to support regulated product submissions, announces that GlobalSubmit 2015 R1 is now available to industry in a variety of deployments. GlobalSubmit 2015 R1 is the production version the U.S. Food & Drug Administration will implement in support of the...

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GlobalSubmit Marks 5th Anniversary of PUBLISH

By on Monday, May 11, 2015 in Press Releases

GlobalSubmit Inc., (www.globalsubmit.com) an industry leader in technology solutions and professional services to support regulated product submissions, is marking five years since the introduction of its eCTD publishing solution. PUBLISH, now the second most used solution for eCTD publishing, relies on the same engine as our REVIEW technology. REVIEW is an industry...

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