GlobalSubmit Announces Version 4.0 for eCTD Review and Validation New Release Delivers Performance Improvements and Enhanced Functionality

Haddon Township, New Jersey (March 5, 2007): GlobalSubmit Inc., leading developer of advanced submissions management solutions for the eCTD, today announced the release of version 4.0 of its flagship software applications GlobalSubmit REVIEW™ and GlobalSubmit VALIDATE™. Since 2005, GlobalSubmit REVIEW and GlobalSubmit VALIDATE have been used exclusively by the U.S. Food and Drug Administration (US FDA) as well as many life sciences companies for the review and validation of electronic submissions based on the eCTD (Electronic Common Technical Document) format. For companies that deliver electronic submissions to the US FDA based on the eCTD format, GlobalSubmit REVIEW and GlobalSubmit VALIDATE have helped to eliminate costly errors before delivering the final dossier and have improved the efficiency of the submissions preparation and review process.

The new release delivers unprecedented features and performance enhancements to assist companies in delivering accurate submissions efficiently to the Agency. Both applications include a significantly improved user interface that enables easy and efficient navigation within your files and within the application. New navigational aids include customizable views and a redesigned menu structure that provides easy access to all application components as well as flexibility to navigate easily between files, tables of content, and different views of your submission. The new features enhance user workspace, thus improving the software ergonomics of the applications and aiding in the day-to-day management of submission documents. Other noteworthy features include:

• Enhanced submissions review and tracking features

• Support for the Health Level Standard (HL7) Regulated Product Submission (RPS)

• Fully integrated support for Adobe Acrobat

•  New Submission Type view that permits organization of an application’s sequences into reviewable units

• Improved Submission Filters to isolate supplements from the original dossier

• Submission Update Function which allows additions to an application after it has been submitted

• Sync with Table of Contents feature to allow for easy navigation between files and locations in the application

"This release is the most comprehensive product on the market”, said Rahul Mistry, CEO of GlobalSubmit. “The key difference in our applications versus others on the market is that we work extensively with the FDA and a team of dedicated industry advisors to develop and deliver functionality both practical and in compliance with regulatory demands. GlobalSubmit Version 4.0 delivers critical features that will help our clients see regulatory submissions just as the regulators see them, avoiding costly errors. This is a ‘must have’ release for any company serious about improving the quality and accuracy of their submissions," Mistry noted.

In support of its application suite, GlobalSubmit is rolling out a new portfolio of consulting services to help organizations adopt and manage the eCTD process. Service offerings will include pilot programs, eCTD readiness services, and teams of regulatory specialists providing on demand services to manage key deliverables for the submissions development and publishing process.

Additional information and a quick tour of the applications are available on GlobalSubmit’s website at www.globalsubmit.com.
 

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