Webinar: Revolutionizing Regulatory Publishing – eCTD v4 Meets Structured Content and AI
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The transition to eCTD v4 is more than a technical update - it is a structural and cultural shift that changes how regulatory submissions are created, reviewed, and maintained. eCTD v4 represents a turning point toward structured data management within a harmonized eCTD environment, designed to strengthen collaboration and data integrity. Docuvera, a pioneer in Structured Content Authoring (SCA), and EXTEDO, a leading provider of end-to-end submission management, are ready for this transformation, providing the tools regulatory teams need to navigate metadata-rich, component-based workflows that enable smarter, faster submissions.
In this webinar, Docuvera and EXTEDO invite you to see how these innovations work together to make eCTD v4 operational reality. By embedding metadata, lifecycle rules, and compliance checks at the point of authoring, SCA ensures that content flowing into eCTD v4 is structured, reusable, and AI-ready while reducing late-stage corrections and enabling smoother, more predictable submission cycles.
A live demonstration will showcase how component-level content can be authored once and reused globally, UUIDs managed efficiently, and lifecycle operations optimized. The session will highlight how combining AI-powered structured authoring with a reliable eCTD v4 submission management empowers all stakeholders, from life science regulatory to health authority assessors, to work smarter, maintain compliance, and accelerate high-quality medicines for global citizens, even as adoption timelines vary across regions.
Join us to learn from industry leaders and see firsthand how SCA and eCTD v4 together are reshaping the future of regulatory publishing - turning a complex transition into a competitive advantage.
EXTEDO and Docuvera are part of cormeo. If you would like to know more about cormeo and the Smart Information Lifecycle, visit https://cormeo.com/.
Why Attend?
- Understand why eCTD v4 is a strategic shift and why it’s more than just a technical upgrade
- See how SCA from Docuvera and EXTEDO’s submission management collaborate to make submissions faster, more accurate, and audit-ready.
- Experience a live demonstration of end-to-end workflows, showing how AI-powered authoring and robust submission management accelerate regulatory operations.
Your Speakers:
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Anjana Pindoria-Rettenberger |
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Kenneth Gutíerrez |