RCM Life Sciences and A-REG Solutions recently hosted the second session in our Regulatory Excellence webinar series: “AI in Regulatory Excellence: How to Elevate Strategy, Quality, and Speed Across the Product Lifecycle.”
This discussion builds on the foundation established in Part 1, “What Regulatory Excellence Really Means,” which explored how early planning, alignment, and data transparency support regulatory success. You can access Part 1 here.
The second session brought together Kelsey Hoontis (Director of Regulatory Affairs, RCM Life Sciences), Anna Hanzlíková (CEO & Co-Founder, A-REG Solutions), and Lucie Svobodova (COO & Co-Founder, A-REG Solutions) for a focused discussion on how artificial intelligence is beginning to influence regulatory operations across the product lifecycle. While AI is advancing rapidly across the industry, the speakers emphasized that regulatory excellence continues to rest on strategy, cross-functional alignment, and human judgment.
Watch On Demand: How AI is Elevating Regulatory Affairs
Artificial intelligence can elevate regulatory decision-making when it is applied with structure, governance, and clarity. The panel shared how AI can support data integrity, strengthen planning, and help teams reduce manual effort so they can focus on higher-value work.
Complete the short form below to access the full webinar recording and Q&A.
Why This Matters for Life Sciences Teams
Regulatory affairs now spans strategy, documentation, digital systems, and cross-functional collaboration. Teams that use AI responsibly can improve the consistency of submissions, strengthen transparency, and accelerate internal decision cycles. The discussion reinforced that AI is most effective when it extends—not replaces—the foundational principles of regulatory excellence.
Redefining Regulatory Excellence
The speakers revisited the idea of regulatory excellence in the context of modern tools and expectations. Rather than focusing solely on error avoidance, excellence was described as a function of strategic clarity, aligned teams, and agile execution.
“A good regulatory strategy can significantly decrease time to market — but it can also bury it if not done well.” — Anna Hanzlíková
“We’ve seen products delayed because the upfront strategy wasn’t clear. It’s not just the answer — it’s the questions you ask up front.” — Kelsey Hoontis
Start Early and Engage Broadly
Early regulatory involvement continues to be one of the strongest predictors of downstream success. Bringing regulatory affairs into early non-clinical, CMC, clinical, and market-access planning supports clearer documentation and reduces last-minute changes during submission preparation.
“Regulatory input should touch all phases — from early discovery to commercial strategy — to build confidence with both internal and external stakeholders.” — Lucie Svobodova
Data Integrity and Transparency Are Non-Negotiable
AI can help teams manage large volumes of regulatory data, but it cannot compensate for inconsistent terminology or unclear documentation. Trustworthy data and traceability remain essential for regulatory acceptance.
“If you don’t say the same thing consistently across your package, you’re just asking for failure.” — Anna Hanzlíková
Make CMC Strategy a Lever for Flexibility
CMC activities can support flexibility when planned with a long-term view. The panel discussed opportunities such as modular dossier structures and early method validation, which allow organizations to respond more efficiently to regional questions and updates.
“Set up your dossier so you can leverage it instead of rewriting it for every site or region.” — Kelsey Hoontis
AI as a Force Multiplier
The panel emphasized that AI is most valuable when it enhances, rather than replaces, the expertise of regulatory professionals. AI can streamline tasks such as document review, formatting, impact assessments, and scenario planning, but human judgment guides interpretation and accountability.
“AI can help you move faster, but it can’t think for you. Regulatory decisions still require human interpretation, context, and accountability — AI is there to enable stronger decisions, not replace them.” — Kelsey Hoontis
“The moment we start treating AI as a substitute for regulatory judgment is the moment compliance breaks down. AI should support your team’s expertise — not automate it away.” — Anna Hanzlíková
“AI works best when it’s paired with people who understand how to question the outputs. It’s a partnership — the technology accelerates, but humans validate and guide.” — Lucie Svobodova
Key Takeaways for Regulatory Teams
- Engage regulatory affairs early in development.
- Build flexibility into strategies and documentation.
- Prioritize clarity, consistency, and traceability of data.
- Strengthen regulatory fluency across functions.
- Apply AI responsibly, with oversight and transparency.
From Compliance to Confidence
As regulatory expectations grow more complex, teams that balance early engagement, sound strategy, and responsible AI usage will be better positioned to accelerate development and strengthen the quality of their submissions. This session offers a practical view of how AI can support regulatory excellence when applied thoughtfully and governed effectively.
If you have not watched the session, scroll back to access the on-demand recording.