Leveraging Technology to Increase Efficiency and Quality for Regulatory Submissions

Abstract

Over the past 5 years, we have implemented several technologies (including eCTD, digital signatures, and the use of FDA's Electronic Submissions Gateway) in the regulatory submissions arena that have enhanced the quality of submissions and improved the efficiency of the submission generation process. In addition to technologies specific to a regulatory submissions group, tools and technologies have been implemented reaching back into the organization to the groups that generate the individual submission components. This article outlines the programs and technologies implemented, which have increased productivity of the submissions staff by more than 30%, while reducing overall spending (full-time employee and capital) by over half a million dollars a year and increasing the overall quality of the dossiers.