Submit With Confidence in 2008!

GlobalSubmit is the market leader in the development of innovative products and services that facilitate and promote the adoption of the eCTD format.  In 2005 GlobalSubmit entered into a cooperative research agreement (CRADA) with the U.S. Food & Drug Administration. Through this initiative GlobalSubmit was asked to develop and deliver a comprehensive solution to replace the FDA's Electronic Common Technical Document (eCTD) Viewing System.  Our solutions help organizations streamline and accelerate the regulatory submissions review process ensuring quality and integrity of each dossier ultimately resulting in faster, more accurate approvals.  These applications are used by leading global life sciences companies as well as the U.S. Food and Drug Administration. 

In addition to innovative products, GlobalSubmit delivers a comprehensive services portfolio to promote the implementation and adoption of the eCTD.  Our services include readiness services, strategic assessment services, pilot programs, software-as-a-service offerings, and flexible outsourced solutions.  Our clients derive significant benefits through our deep domain knowledge and experience in eCTD assembly and publishing.