GlobalSubmit 2014 Released to U.S. Food & Drug Administration, Now Available to Industry

March 17, 2014 - PRLog -- Philadelphia, PA – March 12, 2014 – GlobalSubmit Inc., a provider of end-to-end software and services solutions for delivering high-quality electronic submissions to regulatory authorities, announces that GlobalSubmit 2014 Version 8.0 is now available to industry and has been released to the U.S. Food & Drug Administration for testing and validation. The full software suite is available commercially in a number of deployments, including software as a service (SaaS) or Cloud.

Release of GlobalSubmit 2014 to the FDA does not affect the Agency’s live production environment. Review and validation of incoming submissions are being performed in accordance with a previously installed version of GlobalSubmit software.

GlobalSubmit 2014 includes performance enhancements requested by industry and several regional regulatory updates – notably the ability to accept the new FDA Module 1 (M1) specifications. Recognized as the most substantial change in the history of eCTD, the updated M1 introduces two major activities that were previously impossible:

- All electronic submission of promotional and marketing materials via the FDA’s Electronic Submissions Gateway (ESG)

- Grouped submissions – eliminates the need to submit multiple, identical submissions to different applications.

“The inclusion of M1 changes in this release is the culmination of more than a year of development and testing by our team – along with collaboration with industry and the FDA,” said Jason Rock, chief technical officer of GlobalSubmit. “The focus on M1 shouldn’t overshadow the work we’ve done to ensure compliance with worldwide regulatory  requirements including EMA and Health Canada. Furthermore, we’ve made numerous  enhancements at our clients’ request.”

Adoption of electronic submissions in now prevalent among life science companies. To date, the FDA has processed more than 500,000 sequences. Increased volume of applications requires  greater accuracy and performance, and GlobalSubmit has delivered both in this release.

“We’re even faster than before,” said Rock. “The latest version of our software represents a 20%  improvement in terms of processing speed when compared to old benchmarks. It’s also more
accurate, and for the majority of our end users that increased accuracy will result in an additional jump in processing speed.”

Users of GlobalSubmit 2014 can create compliant eCTD applications for the following regions and versions:

US FDA – 2.01, 3.3
EU – 1.4.1, 2.0 and NeeS
Canada – 2.2
Swissmedic – 1.1
Australia (TGA)

Additional Highlights of GlobalSubmit 2014 include:

- Improved accuracy and processing of links inside PDF files
- Add files from any web interface such as Documentum or SharePoint
- User customization of link appearance
- Create eCTD sequences using US Regional DTD 2.0 or 3.3