The industry is going through major changes in operating procedures. In this time of cost cutting across Research and Development, companies are trying to get their drugs/biologics to market faster and cheaper. To achieve this goal, companies are looking for new ways of getting their submission through the development and review process more efficiently. For this reason, industry has started moving toward electronic submissions, and more specifically toward implementing the Electronic Common Technical Document (eCTD).

Agencies around the world have adopted the Common Technical Document for quite some time, however over the past 5 years they have been more inclined to, and in some cases are requiring that the application be submitted electronically. For instance, the U.S. FDA has seen a rapid increase in the applications that are being submitted in eCTD format. In 2003, the FDA received a total of approximately 100 submissions/sequences in this electronic format, where as in 2008 alone, they are averaging approximately 2000 submissions/sequences a month!1 The adoption of electronic submissions has been seen throughout the industry, from the virtual pharmaceutical/biotech to the industry’s top five pharmaceutical companies. Technology has allowed these organizations to submit in this new format, however it is also requiring them to keep track of all components across the globe. This discussion has been designed to highlight some of the key aspects to the submission management process. We have identified five areas that organizations need to focus on in order to make the application filing process as seamless as possible.