Press Releases

GlobalSubmit 2014 Released to US Food & Drug Administration, Now Available for Industry

Posted by on 6:46 PM in Press Releases | 0 comments

GlobalSubmit Inc., (www.globalsubmit.com) 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 is 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.

US FDA Testing New Module 1 on GlobalSubmit CLOUD

Posted by on 7:21 PM in Press Releases | 0 comments

GlobalSubmit Inc., (www.globalsubmit.com) a provider of end-to-end software and services solutions for delivering high-quality electronic submissions to regulatory authorities, announces that the U.S. Food & Drug Administration is conducting beta testing of its new Module 1 using GlobalSubmit’s CLOUD deployment.

Performing the necessary functionality inspections on the CLOUD has provided the FDA with instant access to changes GlobalSubmit is making at the Agency’s request. This feedback loop is moving the project along at a pace that would not be possible with an on-site installation.

“The real time exchange of information between our development team and the FDA has been invaluable for both sides” said Jason Rock, chief technology officer at GlobalSubmit. “Technically, we’ve been able to verify that completed elements function as expected. Creatively, the back-and-forth has resulted in new feature requests and helped Agency officials gather their thoughts pertaining to industry guidance.”

According to a recent notice posted on its website, the FDA estimates it will be able to receive submissions using the new Module 1 specifications in the 4th Quarter 2014. Industry will be given 30 days’ advance notice.

The long awaited update to the eCTD’s administrative section is designed to:

  • Reflect regulatory changes
  • Provide clarification of business rules for submission processing and review
  • Refine the characterization of promotional marketing and advertising material
  • Facilitate automated processing of submissions

“This is the biggest change in the history of eCTD,” Rock stated.

One of the most consequential changes included in the new Module 1 will give organizations the ability to register multiple products by submitting a single sequence. For example, if one manufacturing facility is responsible for producing Drug A, Drug B and Drug C, the relationship between that lone facility and multiple drugs can be indicated in one submission. Currently a sponsor must file one submission per product. With the new Module 1 implementation a change made pertaining to the facility after the original submission is filed can be applied to all products.