GlobalSubmit 2016 (v10.0) Available to Industry
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 deployments.
Development of GlobalSubmit 2016 R1 (v10.0) focused on improving system performance. Enhancements in this area include
- Quicker system response time when processing large PDF files
- More rapid open of PDF files in GlobalSubmit Cloud environment
- 64-bit memory to provide better support for companies working on large, complex submissions with millions of bookmarks and hyperlinks.
The major release also addressed the increasingly global nature of eCTD. GlobalSubmit is committed to supporting all regions that accept eCTD, and this release makes progress toward that goal. GlobalSubmit 2016 R1 (v10.0) is compliant with the following regional specifications:
- Australia (TGA) Version 3.0
- European Module 1 v3.0.1
- Swissmedic Module 1 v1.3
GlobalSubmit 2016 R1 (v10.0) is available for local installation as well as three (3) cloud deployments—multi-tenant, private, and enterprise.
Headquartered in Philadelphia, PA, with a satellite offices in Boston, MA, and Research Triangle Park, NC, GlobalSubmit is dedicated to facilitating electronic regulatory submissions between life science companies and regulatory agencies worldwide. In addition to developing software for eCTD Submissions Management, Regulatory Information Management and Document Management, we offer a host of regulatory services. Since 2005, GlobalSubmit has been the sole eCTD software provider to the U.S. Food & Drug Administration. The FDA relies exclusively on GlobalSubmit’s REVIEW and VALIDATE platforms to evaluate the technical validity of 100% of the electronic submissions it receives.