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LORENZ Converge 2026 Recap: Regulatory Affairs leaders are shaping the future of eCTD 4.0, AI and RIM in Frankfurt

Posted on October 6, 2026

It is not a question of whether Regulatory Affairs will change. It is a question of how fast you can adapt. That was the tension that filled Frankfurt from September 14–16, 2026, when regulatory professionals from around the world gathered for LORENZ Converge 2026, the international conference for regulatory information management (RIM), eCTD publishing and regulatory data. The event was fully sold out. And by the final evening, one conclusion stood out above all others: the future of Regulatory Affairs is not something to watch unfold. It is something to shape.

LORENZ Converge 2026 participants gathered in front of the Alte Oper in Frankfurt am Main.

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This entry was posted in LORENZ Events.

Simplifying XEVMPD to PMS Data Validation for EMA Migration: How LORENZ EPIC Reduces Manual Effort

Posted on March 12, 2026

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This entry was posted in LORENZ Solutions and Services.

Ready for mandatory EUDAMED registration? How LORENZ drugTrack simplifies Medical Device compliance

Posted on March 3, 2026

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This entry was posted in LORENZ Solutions and Services.

The LORENZ 7 Key RIM Success Criteria

Posted on January 30, 2026

What does it take to make a RIM system truly successful?

After working with 1,000+ customers worldwide, we have identified 7 criteria that consistently drive smarter, more efficient regulatory operations.

From strategic priorities to technical capabilities, these success factors shape the way Regulatory Affairs teams deliver value.

 

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This entry was posted in LORENZ News.

A Year of Progress, Connection, and Innovation at LORENZ

Posted on December 19, 2025

 

This year marked an important chapter for LORENZ. Across events, customer initiatives, regulatory milestones, and product innovation, one thing became clear: regulatory transformation is driven by collaboration, trust, and practical solutions that work in real life.

Whether bringing the global regulatory community together, supporting agencies on their modernization journeys, or helping customers prepare for new standards like eCTD 4.0 and IDMP, LORENZ continued to focus on what matters most, enabling efficient, connected, and future-ready regulatory operations.

Here is a look back at the key topics and milestones that shaped the year.

Our Events: Connecting the Global Regulatory Community

Our annual RIM conference LORENZ Converge took place in Denver. It offered more than 20 sessions, table tutorials, and countless conversations. The engagement, curiosity, and passion of participants once again made Converge a standout event for learning and networking. We are already looking forward to host Converge 2026 in our hometown Frankfurt!

Our free online conference, LORENZ Connect, welcomed nearly 500 participants from over 40 countries. Live sessions allowed regulatory professionals worldwide to share insights and explore trends. Next year, LORENZ Connect will come in a new format, stay tuned!

At our eCTD 4.0 Info Event in Frankfurt, customers and experts explored how the next-generation submission format will impact regulatory workflows. With agencies already announcing timelines, LORENZ continues to guide customers through this transition, building on decades of experience. Experience the atmosphere in this video.

Supporting Agencies: MHRA & HSA

This year, LORENZ supported major regulatory milestones. Singapore’s HSA went live with its new eCTD Portal, while the UK’s MHRA successfully migrated to a modern submission platform. Our software is currently used by 19 authorities worldwide, with solutions such as docuBridge, eValidator, and Automator supporting these initiatives as part of our ongoing work in the regulatory landscape.

The 7 Key RIM Success Criteria

After working with 1,000+ customers , we identified seven criteria that consistently make RIM systems successful. From strategic alignment to technical capabilities, these factors shape how Regulatory Affairs teams deliver real value.

If you do not want to miss this or any other news in the future, follow us on LinkedIn to catch the full overview and stay up to date.

PMS Enrichment: Turning IDMP into Reality

LORENZ was among the first to deliver PMS Enrichment to EMA’s Production system. With API Write Access live since September 2025, this milestone supports structured data initiatives and real-world implementation of IDMP standards. Visit our website for more information.

Empowering Regulatory Review with LORENZ verifAI

This year, verifAI saw significant further development. Designed to automate your review process, it can be used for submissions by authors, regulators and publishers. verifAI automatically validates eCTD content for accuracy, completeness, and compliance, while also checking consistency against historical documents and across multiple eCTD sequences.

Trusted Regulatory Spaces: From Vision to Reality

Trusted Regulatory Spaces (TRS) made further progress this year. Across multiple initiatives and collaborations, LORENZ continued to work with partners and industry experts on topics such as interactive review processes, regulatory reliance, and secure data sharing. A meeting in Frankfurt brought partners together to advance these discussions, while initiatives like PRISM and CRYPTx illustrate the broader momentum behind the future of regulatory exchange.

Looking Ahead

From events and agency collaborations to product innovation and forward-thinking concepts, 2025 was a year of progress. We are excited to keep shaping the future of regulatory affairs, together with our partners, customers, and community.

 

 

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This entry was posted in LORENZ News.

The 25.2 releases of the LORENZ RIM solution are here: drugTrack, eValidator, and docuBridge

Posted on October 31, 2025

Release Highlights:

What's new in LORENZ RIM? The User Notification Center now offers improved preference settings, including an Opt-Out per Category option, giving you full control over which notifications you receive. The updated Best Practice Configuration has also been refined based on customer feedback and real-world experience, making it easier for new users to get started and for existing ones to benefit from smoother setup processes. Available for both cloud and on-premise customers, it now includes broader Assisted Compilation coverage, overall usability improvements, and simplified upgrade options requiring less manual effort. Discover more about these features here: What's new in RIM 25.2?

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This entry was posted in LORENZ Solutions and Services.

Sneak peek: Four Ways our 25.2 release will make your regulatory life easier

Posted on October 27, 2025

Sneak peek at a 25.2 RIM feature:

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This entry was posted in LORENZ Solutions and Services.

Building Connections, Sharing Knowledge: The Story of the LORENZ docuBridge userGroup

Posted on October 7, 2025

Have you ever found yourself struggling to interpret an agency guideline or looking for the most efficient way to structure a submission? You are not alone and that is exactly why the LORENZ docuBridge userGroup was created.



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This entry was posted in LORENZ News.

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