IRAS Inc is using the Lorenz DocuBridge One software as the publishing tools. It also includes a validation tool to ensure the submission will pass the FDA electronic validation.

Most of regulatory agencies are moving toward electronic publishing using the Common Technical Document (CTD) per ICH guidelines.

The benefit of using the eCTD format across multiple product applications is to provide a single core dossier with consistency for the location of information such that a change common to all sponsor applications can be implemented across the applications by changing just one component CTD section.