At A Glance

GlobalSubmit at a Glance

Complete Confidence when Submitting your Application

GlobalSubmit is an innovator and thought leader in the field of regulated healthcare products. We continue to improve on our intuitive software suite, and offer an array of professional services associated with eCTD submissions. GlobalSubmit’s eCTD suite is a complete software solution with a verifiable track record consisting of platforms designed to publish, validate, and review eCTD submissions, as well as build hyperlinks and bookmarks. Since 2005 we’ve been the sole provider of eCTD solutions to the U.S. Food & Drug Administration. The FDA relies exclusively on our REVIEW™ and VALIDATE™ software products to process 100% of the electronic submissions it receives. We recently renewed our license agreement with the FDA, and value the input and insight available to us as a result of this relationship.

Cognizant of the changing conditions within the industry, we’ve redoubled our effort to offer an array of professional services and regulatory consulting. We’ve also made our full software suite available in the Secure CLOUD. These developments appeal to virtual and small companies who grapple with overstretched in-house resources, limited IT infrastructure, the reality of tight deadlines and reservations about submitting electronically for the first time.

While competing vendors drift away from a focus on technological innovation that benefits end users, and the industry as a whole, GlobalSubmit continues to refine its products and processes by welcoming feedback. Our software platforms present a vantage point identical to that of the reviewers at the FDA, giving our clients confidence and peace of mind when submitting their applications.

With these definitive advantages, you can sleep at night with the assurance that your submission is FDA-ready. The question remains, why aren’t you using GlobalSubmit?