Press Releases

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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GlobalSubmit Launches Pair of RIM Products

GlobalSubmit Launches Pair of RIM Products

By on Tuesday, January 10, 2017 in Press Releases

COMMUNICATE, MANAGE Now Available to Industry Philadelphia, PA – January 10, 2017 GlobalSubmit Inc., (www.globalsubmit.com) an industry leader in regulatory technology solutions and services to support global life sciences submissions, is adding a pair of regulatory information management (RIM) products to its portfolio. The RIM products comprise a novel, long...

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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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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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