The electronic Common Technical Document (eCTD) standard has evolved many times over the past 20 years, and its current version, v3.2.2, will soon be supplemented with the introduction of the next major version - eCTD v4. At its core, eCTD v4 is a format change that gives users access to significant new capabilities.

In this white paper, we will explore the evolution of the eCTD format, what is changing in the next major version, and what the objectives and focal points of eCTD v4 are. Furthermore, we will outline the benefits and challenges associated with the transition from eCTD v3.2.2 to v4 - both from a technical and regulatory perspective.


Questions about eCTD v4 answered in this white paper: 

- What is eCTD v4, and how does it differ from eCTD v3?

- What are the primary objectives of eCTD v4?

- What benefits does eCTD v4 offer to life science organizations?

- How will the transition to eCTD v4 impact regulatory submissions?

- What role does EXTEDO play in the transition to eCTD v4?


Download our white paper now to discover detailed information about eCTD v4 and how it will affect your existing life science business processes.

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