eCTD Publishing

To ensure that Common Technical Documents (CTDs) are submitted in a standard (eCTD) publishing format, the FDA is requiring that the transfer of regulatory information to the agency may only be done electronically.

As the era of electronic-only eCTD publishing and submissions begins, it is assumed that companies soon won’t even be able to communicate to the FDA without some type of eCTD publishing-friendly electronic system. If your life science company is preparing to “go electric” and commence the daunting task of eCTD publishing, there are a few important tips and tricks you should know before turning in your final submission.