In 2025, Ennov did what we’ve always done best: worked closely with the life sciences industry to deliver a unified compliance platform that keeps pace with regulatory change, operational complexity, and growing data demands.
This year was about continued progress: strengthening the platform, expanding real-world use cases, and supporting our global community as they prepare for what’s next.
Building Community
Community and collaboration remained at the center of everything we did in 2025.
We launched the Ennovation Podcast and released six episodes that reached over 700 listeners. Each one brought practical insight from leaders across regulatory, quality, clinical, and safety. A sincere thank you to our guests for sharing their experience, and to Alice Merrill, our host, for guiding thoughtful, industry-grounded conversations.
We also brought customers and partners together in person at three Ennov User Meetings in France, Europe, and the United States. Over 300 attendees joined us to exchange ideas, challenge assumptions, and influence product direction. These conversations continue to shape how Ennov evolves, keeping innovation grounded in real operational needs.
Our Ennovation LinkedIn newsletter now reaches nearly 20,000 followers. This is a community that’s growing across regions and disciplines, all looking for better ways to connect regulatory, quality, clinical, and pharmacovigilance operations.
Progress in eCTD 4.0
In 2025, Ennov completed eight successful eCTD 4.0 pilot projects with customers—two for Japan and six for the European Union. Combined with three FDA pilots from previous years, this brings our total to 11 successful pilots.
This also means Ennov has participated in every eCTD 4.0 pilot conducted to date, reinforcing our leadership and hands-on experience across all active regions.
This progress comes at a critical moment: the EMA has announced it will begin accepting eCTD 4.0 submissions from 22 December 2025, marking a major milestone in the transition to the new standard. Ennov customers are well positioned to move forward with confidence.
IDMP Readiness That Actually Works
Ennov delivered the only solution that sends IDMP-ready data directly to PMS, connecting seamlessly to Ennov RIM or any third-party RIM system. What used to take 12 hours of manual enrichment per product now takes just five minutes with Ennov’s Agnostic Solution for IDMP (EASI). Customers are already using EASI to prepare for the June and December 2026 enrichment deadlines
Ennov 11.0: Our Most Advanced Release Yet
2025 also marked the release of Ennov 11.0, bringing AI directly into the platform with full traceability, validation, and security built in from day one.
Ennov AI is now available as an optional module. Features are designed to speed up routine work without compromising compliance, including:
- An embedded chatbot that answers questions and surfaces records
- Auto-classification for eCTD documents
- AI-driven capture and extraction of health authority correspondence
- Instant quiz generation from SOPs
- AI-driven case narrative extraction for pharmacovigilance
We also introduced a new global homepage that acts as a control center: role-based dashboards, actionable queues for reviews and signatures, and real-time compliance indicators all in one place.
Looking Ahead
As we head into 2026, we remain focused on what matters: unified workflows, smarter AI, and making sure our customers are ready for whatever regulatory changes come next.
We’re excited to reconnect with our customer community at the Ennov User Meeting in Denver, April 27–29, 2026, with more regional events throughout the year.
To our customers, partners, and community—thank you. Here’s to 2026.
