All Electronic Common Technical Document (eCTD)

What is an Electronic Common Technical Document eCTD?

Electronic Common Technical Document (eCTD) software is used to prepare and submit regulatory documents to health authorities. It organizes clinical, non-clinical, and quality data into a standard format required by agencies like the FDA and Health Canada. The software helps teams build, edit, validate, and publish submissions quickly and accurately.

eCTD software creates structured documents using predefined modules and folders. It checks each submission for errors and ensures that all required sections are included. The system also tracks versions and maintains a complete record of all changes. Regulatory teams use eCTD platforms to manage large volumes of documents across multiple submissions and regions.