The RCM Life Sciences Regulatory Affairs team partnered with A-REG Consulting to explore a topic that’s often mentioned but rarely defined in practice: regulatory excellence.
Hosted by Lucie Svobodova (COO & Founder, A-REG), Anna Hanzlíková (CEO & Founder, A-REG), and Kelsey Hoontis (Director of Regulatory Affairs, RCM Life Sciences), the session took a closer look at what regulatory excellence means in day-to-day operations.
Watch On Demand: What “Regulatory Excellence” Really Means
Regulatory excellence is more than theory. It serves as the foundation for how leading life sciences companies bring therapies to market with clarity, speed, and confidence.
Hear from industry experts as they share practical insights on how strategic alignment, data integrity, and early regulatory planning create a competitive advantage.
Complete the short form to access the full on-demand recording and expert Q&A.
Redefining the Role of Regulatory Affairs
Today’s regulatory teams are evolving from transactional “gatekeepers” to strategic partners, influencing early planning across non-clinical design, CMC strategy, and clinical pathways.
“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.” — Kelsey Hoontis
In short, regulatory excellence = clarity of strategy + functional alignment + execution agility.
Key Themes from the Discussion
1. Start Early, Engage Broadly
Regulatory input should begin as early as possible—touching non-clinical, clinical, CMC, and market-access planning.
“As early as possible with more stakeholders… our regulatory department should be involved.” — Lucie Svobodova
2. Data Integrity + Transparency = Trust
Submissions depend on well-structured, traceable data. Consistency of language and documentation builds confidence with agencies.
“If you don’t say the same thing consistently across your package… you’re just asking for failure.” — Anna Hanzlíková
3. CMC Strategy as a Lever for Flexibility
Anticipatory CMC planning—such as early method validation or modular dossier design—creates long-term agility.
“Set up your dossier so you can leverage it instead of rewriting it for every site.” — Kelsey Hoontis
4. Regulatory Excellence is Holistic
True excellence thrives on cross-functional collaboration, with regulatory acting as the connective tissue across R&D, CMC, clinical, and market access.
“A well-functioning regulatory team means the company doesn’t even realize it exists.” — Lucie Svobodova
5. AI and Digital Tools Require Integrity
Emerging technologies can improve efficiency—but only when paired with transparency and human oversight.
“Integrity and transparency have to be there.” — Kelsey Hoontis
What It Means for Your Organization
- Embed regulatory strategy early: Involve regulatory affairs from preclinical design through market prioritization.
- Design with flexibility: Build modular strategies that anticipate change rather than react to it.
- Focus on data clarity: Use consistent terminology and structure to build trust with regulators.
- Promote regulatory fluency: Help non-regulatory teams understand the reasoning behind key decisions.
- Use AI wisely: Leverage automation responsibly, maintaining transparency and oversight.
Continuing the Conversation
This conversation is part of an ongoing webinar series exploring the evolving role of regulatory affairs in life sciences. The next session, “AI in Regulatory Affairs: Practical Benefits and Pitfalls,” will highlight case studies, governance models, and real-world applications of AI in regulatory operations. Stay tuned for details.