The eCTD is a collection of documents in compliance with regulatory legislation and guidelines. It is compiled by a pharmaceutical or medical devices company or its agent, to obtain marketing authorization for their product.
The purpose of the document is to assemble all the quality, safety, and efficacy information related to medical devices and pharmaceutical drugs in a standard format (XML or PDF).
How does structured content authoring help?
Several departments, teams, and organizations work on creating and assembling the eCTD submission file. It is a complex task that requires a high level of collaboration between internal and external teams, as the involvement of external agencies is mandated through regulatory norms. As a result, multiple documents are created and reviewed by sometimes hundreds of people.
A structured content authoring and reviewing online tool can help all the various teams streamline the process, work efficiently and shorten time-to-market.