Posts by bunderwood

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 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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