The transition to eCTD v4 is more than just a technical update – it represents a structural and cultural evolution in regulatory submissions. eCTD v4 marks a pivotal move toward structured data management within a harmonized eCTD environment, aimed at strengthening collaboration and ensuring data integrity. Since our founding, our goal has been the Smart Information Lifecycle, which enables integration at various points in the regulatory process.
As part of cormeo, Docuvera – an innovator in Structured Content Authoring (SCA) – and EXTEDO – a leading provider of end-to-end submission management – are prepared for this transformation. They deliver the advanced tools regulatory teams need to navigate metadata-rich, component-based workflows for smarter, more efficient submissions.
In this webinar, Docuvera and EXTEDO will demonstrate how these capabilities work in tandem to make eCTD v4 an operational reality. By embedding metadata, lifecycle rules, and compliance checks directly at the authoring stage, SCA guarantees that content flowing into eCTD v4 is structured, reusable, and AI-ready, all while reducing late-stage corrections and enabling more consistent, predictable submission cycles.
A live demonstration will showcase how component-level content can be authored once and reused globally, UUIDs can be managed seamlessly, and lifecycle operations can be optimized. The session will illustrate how the combination of AI-powered structured authoring and robust eCTD v4 submission management enables all stakeholders – from life sciences regulatory teams to health authority assessors – to work more effectively, maintain compliance, and accelerate access to high-quality medicines worldwide, even as adoption timelines vary by region.
Join us to learn from industry leaders and experience firsthand how Structured Content Authoring and eCTD v4, supported by the cormeo ecosystem, are reshaping the future of regulatory publishing—making a complex transition a true competitive advantage.
Why Join This Event?
- Gain strategic insights into how eCTD v4 represents a fundamental change for regulatory submissions – far beyond a simple technical update
- Discover how Structured Content Authoring from Docuvera combined with EXTEDO’s submission management, streamlines processes for faster, more accurate, and audit-ready submissions
- Experience a live demonstration featuring end-to-end workflows, and learn how AI-enabled authoring and robust submission management drive operational speed and reliability for regulatory teams
Register Now
Secure your spot by filling out the registration form on EXTEDO's website!