Access to Free Portal Revolutionizes Preparation of FDA-Compliant Submissions

FOR IMMEDIATE RELEASE, Philadelphia, PA—May 15, 2008. GlobalSubmit, leading developer of advanced submissions management solutions for the eCTD, today announced the availability of a new XPortal directly accessible from its corporate website.  In collaboration with the U.S. Food and Drug Administration (U.S. FDA), the innovative XPortal is a revolutionary new way to prepare electronic submissions for the FDA. Under the direction of the FDA, GlobalSubmit has developed XForms that capture RPS (Regulated Product Submissions), ICSR (Individual Case Safety Report), SPL (Structured Product Labeling) and Stability.

The key benefits of the XPortal are:

• Free preparation of FDA-compliant submissions for Structured Product Labeling, Regulated Product Submissions, Individual Case Safety Reports, and stability data without the need to purchase software or engage outsourcing partners.

• Decrease in preparation time by effectively developing and delivering electronic submissions, thereby eliminating the need to create paper submissions.

• Improve the support for public health and safety initiatives by allowing the electronic submission of critical data.

Jason Rock, Chief Technology Officer at GlobalSubmit, comments: “We are pleased to announce the availability of XPortal, linked to our corporate website. This technology represents a significant paradigm shift for submission preparation and delivery by eliminating the reliance on cumbersome traditional paper processes. Our team is excited to work with the FDA with the goal of assisting industry in delivering mission-essential information for public health and safety, quickly and efficiently, to the FDA.”

Users can register, free of charge, for XPortal access at www.globalsubmit.com/xportal/login. XPortal is fully web-based. Therefore, no software is downloaded onto your computer, and all XPortal functionality is available online.

The key features of XPortal include:

• Secure logon to forms

• Save forms for later edits

• Upload document files

• Attach document files to forms

• Download document files to work offline

• Output forms in FDA-required file formats

In support of XPortal adoption, GlobalSubmit offers workshops and training seminars to help users leverage XPortal functionality in their unique environment. For more information, visit www.globalsubmit.com.

ABOUT GLOBALSUBMIT

GlobalSubmit is the eCTD market leader of innovative products and services that facilitate and promote adoption of the eCTD format. GlobalSubmit’s flagship applications, GlobalSubmit REVIEW and GlobalSubmit VALIDATE, are used by leading global life science companies as well as the U.S. Food and Drug Administration. Our solutions help organizations streamline and accelerate the regulatory submissions review process, thus ensuring the quality and integrity of each dossier and creating the ultimate result of faster and more accurate approvals. GlobalSubmit is based in Philadelphia, PA.

 
 BACK TO PRESS RELEASES