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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.

 

 

This entry was posted in LORENZ News.

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.



This entry was posted in LORENZ News.

Since 2020, LORENZ has used DocShifter’s advanced technology in its cloud offerings to streamline document conversion into compliant PDFs. This collaboration has delivered fast and efficient processes, allowing customers to save time and focus on their business goals.

Building on the success of this partnership in the cloud, LORENZ is now extending the advantages of DocShifter to its on-premises customers. By integrating DocShifter as a standard feature across all LORENZ docuRender implementations, LORENZ delivers a unified and future-ready platform designed to enhance functionality for both cloud and on-premises environments.

 

This entry was posted in LORENZ News.

Milestones and Memories of 2024 (part4)

Posted on December 20, 2024

Welcome to the final chapter of our 2024 journey! As we reflect on an eventful year filled with milestones, memories, and meaningful connections, we are proud to share some of our most memorable moments.



This entry was posted in LORENZ News.

Milestones and Memories of 2024 (part 3)

Posted on December 16, 2024

What a year! Join us as we look back on amazing events, unforgettable moments and major successes with our customers!



This entry was posted in LORENZ News.

Milestones and Memories of 2024 (part 2)

Posted on December 9, 2024

As we approach the end of 2024, it’s time to reflect on an incredible year filled with achievements, milestones, and inspiring moments. At LORENZ, this year was defined by innovation, community, and creativity, leaving us proud of the journey we’ve shared.



This entry was posted in LORENZ News.

Milestones and Memories of 2024 (part 1)

Posted on December 3, 2024

What a year! Join us as we look back on amazing events, unforgettable moments and major successes with our customers!



This entry was posted in LORENZ News.

Established in December 2021, the drugTrack userGroup was directly inspired by the success of its sister, the docuBridge userGroup. It is run by users and supported by LORENZ to share insights on working with LORENZ drugTrack.



This entry was posted in LORENZ News.

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