eCTD Publishing

Electronic submissions done right

Based on the content of the Common Technical Document format, the Electronic Common Technical Document transfers regulatory information from industry to agency in electronic form.

The electronic Common Technical Document (eCTD)

Based on the content of the Common Technical Document (CTD) format, the Electronic Common Technical Document (eCTD) transfers regulatory information from industry to agency in electronic form. The technical components consist of a high level folder structure, XML based metadata, document type definitions (DTDs) and stylesheets.

All types of regulatory information can be submitted in electronic format, including new applications, variations and renewals for national, mutual recognition, decentralised and centralised procedures.

How we support you

Handling eCTD submissions requires precision, expertise, and the right tools. At QbD Group, we provide comprehensive support to ensure your electronic submissions are efficient, compliant, and meet regulatory standards. We help you with:

Validate and select eCTD software

We help you evaluate, validate, and select the most suitable eCTD software for your organization.

Compile accurate & compliant eCTDs

Complete compilation and publication of eCTD submissions for all procedure types.

Prepare and submit electronic applications

End-to-end preparation and submission of electronic applications to regulatory authorities.

Ongoing eCTD maintenance and support

Continuous eCTD lifecycle support including variations, renewals, and technical validation.

How to create eCTDs

The files in an eCTD should be organized according to the version 3.2 of the ICH eCTD specifications and the current version of the EU Module 1 specifications. The eCTD consists of (mostly) PDF leaf documents, stored in the eCTD directory structure, crucially accessed through the XML backbone (index.xml) and with the files integrity guaranteed by the MD5 Checksum.

In order to use eCTD, marketing authorization holders need to invest in appropriate software and maintain support systems.

Why QbD Group

Your trusted partner

Choosing QbD Group means partnering with a trusted leader in Regulatory Affairs. With over a decade of expertise, we provide tailored support across the entire product lifecycle, ensuring seamless compliance and customer satisfaction on a global scale.

10+ years of experience: benefit from our team of highly qualified consultants.

Full life cycle support: full support from pre- to the post-marketing phase.

Global presence: QbD Group operates globally, with QbD Austria having a special focus on Europe (EU) and China.

Customer satisfaction: constant evaluation, transparency and clear objectives.

Let's talk Regulatory Affairs

From regulatory strategy to product approval, our experts are ready to guide you through every step.