Philadelphia, PA—July 7, 2009-
, a leading developer of software designed exclusively for the review and validation of electronic Common Technical Document (eCTD) global submissions, announces that it has signed a three-year Maintenance and Support Agreement with the FDA. Per the agreement, GlobalSubmit will enhance and/or upgrade the GlobalSubmit REVIEW™ and VALIDATE™ software products already in use at the Agency. A previous three-year Maintenance and Support Agreement between GlobalSubmit and the FDA ended in June, 2009. The new agreement serves to continue the symbiotic relationship shared by GlobalSubmit and the Agency as both organizations work to establish a standard electronic regulatory submission environment. Commenting on the significance of this new agreement, Rahul Mistry, CEO, GlobalSubmit, stated, “We are very pleased to be able to continue this aspect of our relationship with the FDA. Per this agreement, we will work closely with reviewers at the FDA, collecting their requests and delivering the enhancements and upgrades needed to make the electronic submission environment a workable reality.” Currently, GlobalSubmit’s REVIEW and VALIDATE products are used by reviewers at CDER (the Center for Drug Evaluation and Research), at CBER (the Center for Biologics Evaluation and Research), and by reviewers at life sciences companies worldwide.
GlobalSubmit is a products and services company that provides transparency in regulated healthcare products. The U.S. Food & Drug Administration and leading life sciences companies use our flagship applications, REVIEW™ and VALIDATE™, to review and validate electronic submissions. GlobalSubmit leads international efforts, comprising industry and government agencies, to standardize product and study information. The company is headquartered in Philadelphia, Pennsylvania.