De-Risking Regulatory Strategy with AI-Powered Global Insights: A Solutions Spotlight on Dr. Evidence

?? RAPS Global Regulatory Strategy Conference | March 11, 2025 | Baltimore, MD

Regulatory strategy requires compliance, precision, efficiency, and proactive risk management to prevent costly missteps.

The ability to quickly gather, analyze, and act on regulatory intelligence is more critical than ever. Yet, many regulatory teams still rely on manual processes, fragmented datasets, and time-consuming workflows that create unnecessary delays.

At the RAPS Global Regulatory Strategy Conference, Rose Higgins, CEO of Dr. Evidence, led a Solutions Spotlight session on how AI-powered tools are transforming the way regulatory professionals approach intelligence gathering, risk assessment, and submission strategy.?

The session, titled “De-Risking Regulatory Strategy with Evidence-Driven Insights from Across the Global Landscape, Powered by AI,” explored best practices in streamlining data collection and analysis to support faster, more informed regulatory decision-making.

The Challenge: Regulatory Intelligence Overload

The sheer volume of global regulatory data is overwhelming. Pharmaceutical and medical device companies must track guidance across multiple jurisdictions, align with evolving regulatory expectations, and respond to submission inquiries—all while ensuring accuracy and compliance.

The problem?

• Regulatory teams spend too much time manually searching, copying, and formatting data from multiple sources—an inefficient process prone to errors and inconsistencies.
• The regulatory landscape constantly shifts, making maintaining?a real-time, centralized source of truth?across global markets difficult.
• Without AI-powered analysis, teams may miss critical insights, leading to delayed approvals and strategic misalignment.

“We refer to it as the ‘What’s in Your Browser’ problem,” Higgins explained, referencing the common regulatory challenge of toggling between dozens of open tabs, scattered documents, and disconnected databases to compile intelligence manually.

The Solution: AI as a Regulatory Co-Pilot

Dr. Evidence’s platform leverages AI and natural language processing to turn regulatory data chaos into structured, actionable intelligence. Instead of wasting time hunting for relevant precedents or tracking fragmented updates, AI-enabled solutions can:

? Aggregate global regulatory intelligence in real-time—pulling from FDA, EMA, WHO, PubMed, clinical trial databases, and country-specific sources.

? Identify critical trends and risk factors early—allowing regulatory teams to make more proactive, evidence-based decisions.

? Eliminate duplication and manual effort—reducing time spent on data entry, formatting, and cross-referencing.

? Improve cross-functional collaboration—helping regulatory teams align with clinical, commercial, and market access stakeholders faster and more effectively.

AI in Action: Smarter Submissions, Fewer Delays

One of the key benefits of AI in regulatory strategy is its ability to improve the efficiency of regulatory submissions and responses.

• Automating Intelligence Gathering – AI can scan and synthesize regulatory precedent, clinical data, and labeling requirements across multiple jurisdictions, giving teams faster, more precise insights.
• Streamlining Regulatory Submissions – By organizing and structuring regulatory data before it’s even submitted, AI can help teams anticipate and mitigate regulatory inquiries before they happen.
• Enhancing Real-Time Monitoring – AI-powered systems can provide alerts on relevant regulatory updates, ensuring that regulatory strategies remain agile and current.

One session attendee noted the impact of AI-driven regulatory monitoring, explaining how their organization used AI to track risk signals across different regulatory bodies—allowing them to respond to inquiries faster and more confidently.

Higgins reinforced this point, emphasizing that automation isn’t about replacing regulatory expertise—it’s about enhancing it.

“There’s no scenario where AI should be running ‘unfettered,’” she explained. “Human oversight is critical—AI can accelerate intelligence gathering and streamline workflows, but regulatory professionals must validate and contextualize the insights.”

The Future of AI in Regulatory Strategy

As AI adoption grows, the role of regulatory professionals will continue to evolve. Companies that embrace AI-driven regulatory intelligence can expect:

• More efficient, data-driven decision-making, reducing unnecessary delays in global market entry.
• Stronger risk management, enabling regulatory teams to identify compliance gaps before they become issues.
• Improved collaboration across regulatory, clinical, and commercial functions, ensuring that regulatory strategy aligns with business objectives.

The session concluded with a call to action for regulatory leaders—AI is not a distant future tool; it’s a competitive advantage today. Those who implement AI strategically will reduce risk, optimize their workflows, and ultimately improve their ability to bring products to market faster and more efficiently.

As AI transforms regulatory affairs, success depends on accessing data and using it effectively to drive smarter decisions.

Join Us Next Week

Looking forward to more discussions on AI-driven transformation in regulatory strategy at the RAPS Regulatory Intelligence Conference (March 13-14).

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