At our recent Regulatory Forum, we discussed the increasing volume, velocity, and complexity of regulatory changes facing life sciences organizations. For instance, the FDA alone issued 101 guidance documents annually from 2005–2010, 173 from 2011–2019, and over 190 in FY 2023*. The reality facing regulatory intelligence practitioners is they may have to be monitoring updates from over 150 countries and 300 authorities every day. Across all of the different authorities and sources this is potentially hundreds if not thousands of updates** per year. This vast amount of information can easily obscure critical insights.

The complexity of communication channels, including social media, adds to the challenge. Regulatory changes impact compliance, research and development, competitive advantage, and product timelines. Even post-COVID-19, the pace of updates continues to rise as agencies strive for better patient outcomes. To navigate this landscape, regulatory intelligence must evolve from manual processes to AI-enabled, integrated systems.

This article explores AI regulatory intelligence, its importance, implementation strategies, common pitfalls, and how Infodesk can assist.

* Trends in Oncology Regulation: FDA Draft Guidance on OS and Radiopharmaceuticals and **(33) Biotech and Pharma Regulation (2021–2025): Global Shifts, Market Impact & Future Outlook | LinkedIn

 

What is AI regulatory intelligence?

AI regulatory intelligence consolidates fragmented updates from agencies like the MHRA, applying artificial intelligence to monitor and curate relevant insights. It contextualizes information for specific businesses or products, enabling regulatory professionals to communicate effectively with SMEs and support decision-making.

An effective AI regulatory intelligence solution provides clarity during critical moments, monitors relevant changes, and facilitates swift, confident decisions.

Key features of AI regulatory intelligence

  • Horizon-Scanning Surveillance AI Filters: Focus on relevant updates while eliminating duplication and irrelevant content.
  • AI Categorization: Adapt monitoring to emerging topics and technologies, allowing for tailored insights.
  • AI Co-Pilot: An assistant that refines outputs and generates actionable intelligence from various document types.
  • AI Search and Answer: Use natural language queries for quick, contextual searches.
  • AI Saved Searches and Alerts: Save searches and receive timely notifications on relevant topics.
  • AI-Powered Summaries: Automatically generate concise summaries aligned with regulatory priorities.
  • Safe Walled Garden AI: Rather than using one of the large, generic LLM AI platforms you should ensure data integrity by using trusted AI-powered platforms, where you can completely trust the data and sources, and always be able to trace insights back to the original source, and therefore be confident about the outcomes.

 

Life before AI regulatory intelligence

We have heard from the attendees at our Regulatory Forum and from our own customers that regulatory intelligence professionals in life sciences businesses are on a journey. Regulatory intelligence professionals are transitioning from manual, siloed tasks working in Excel to technology-driven processes that save time and enhance focus on high-value work. Previously, professionals spent:

  • 10-12 hours weekly searching for updates and analyzing impacts.
  • 10 hours per week gathering recommendations from SMEs.
  • 2-3 hours per week triaging briefings.

These manual processes are time-consuming and prone to errors, risking compliance issues. AI regulatory intelligence can reduce costs by over 50%, allowing resources to be redirected to value-added actions.

 

Why is AI regulatory intelligence useful in life sciences?

The regulatory landscape is increasingly complex. AI regulatory intelligence helps businesses navigate this complexity efficiently. Key challenges include:

  • Rising complexity and volume: Health authorities issue more guidance than ever, straining resources.
  • Manual surveillance methods: Reliance on outdated methods leads to missed updates and delays.
  • Lack of strategic visibility: Teams struggle to prioritize without a comprehensive view of changes.
  • Delayed internal awareness: Critical updates often reach stakeholders too late.
  • Blind spots in global markets: Local developments can be overlooked, exposing compliance risks.
  • Disconnected workflows: Siloed tools hinder collaboration and slow decision-making.

Benefits of AI regulatory intelligence

  • Faster time to market through early signal detection.
  • Improved compliance during launch and post-market phases.
  • Enhanced cross-functional coordination.
  • Auditable trails for regulatory changes.

Building an AI regulatory intelligence capability

 Learned from our customers, here are some practical hints and tips for building your AI regulatory intelligence capability for your team and life sciences organization.

Design a regulatory intelligence framework

This is a process map for your overall regulatory intelligence organization and capability. Chris Whalley, Senior Director and Head of Global Regulatory Intelligence and Analysis at Pfizer, recently presented his regulatory intelligence framework which comprised four capabilities, and each capability involves people, processes, and technology, forming a comprehensive model for regulatory intelligence:

  1. Observe: Monitor potential updates.
  2. Communicate: Notify stakeholders.
  3. Evaluate: Assess the impact of new intelligence.
  4. Act: Implement changes based on evaluations.

Define your scope

Identify relevant regulatory domains and set performance goals for stakeholder teams.

Assemble the right sources and data flows

Incorporate external regulatory sources and internal documents, using AI to tag and classify them.

Curate and validate

Ensure human validation for relevance and context, establishing governance roles.

Integrate into workflows

Link alerts to actionable tasks, assign owners, create cases for impact assessments and encourage feedback loops to measure impact.

Monitor, refine, and scale

Establish metrics for performance and periodically review your processes.

Common pitfalls and how to avoid them

  • Irrelevant alerts: Use relevance-filtering and human review.
  • Alerts without actions: Tie changes to specific tasks.
  • Siloed intelligence: Integrate workflows across teams.
  • Lack of audit trail: Ensure traceability for audits.
  • Using one of the large, generic LLMs: These have not been trained to learn the regulatory or life sciences taxonomy and may not be using trusted sources so they will produce dubious results.

 

Why partner with Infodesk for AI regulatory intelligence

Infodesk offers a centralized platform that transforms regulatory complexity into strategic clarity. Our AI-driven solution for Life Sciences helps teams reduce compliance risks and respond swiftly to developments. With experienced analysts and editorial curators, we deliver timely, accurate intelligence tailored to your needs.

  • Only Infodesk delivers regulatory intelligence activation which enables you to convert regulatory complexity into strategic clarity with current, curated intelligence all in one centralized place.
  • Only Infodesk offers a Regulatory Workflow Solution which connects regulatory intelligence into action for GxP Quality Compliance teams who need to take reg intel and deliver impact assessments, create cases, and assign tasks to SMEs.
  • Infodesk’s regulatory intelligence solution is built for today’s regulatory challenges. Infodesk helps regulatory teams reduce compliance risk, coordinate faster, and respond decisively to regulatory developments.
  • A safe walled garden: The content curated in Infodesk is all from trusted sources.
  • The Infodesk SaaS platform uses AI to help complex organizations transform overwhelming volumes of information into relevant, trusted intelligence, streamline workflows, empower teams, and make confident decisions when timing, traceability, and coordination are key.
  • Infodesk is human-first, AI- powered. We offer managed professional services where we put experienced analysts and editorial content curators to work for you, delivering trusted intelligence that’s timely, accurate, and ready to use. Working closely with you from the outset to understand your priorities, they’ll work with you side-by-side and adapt as your requirements evolve, ensuring ongoing relevance and value.
  • Partnering with us reduces the burden on you and your team and frees regulatory teams from manual monitoring, ensures speed and relevance, and tracks end-to-end from monitoring to action.

Download the Infodesk Regulatory Intelligence Solution Brochure or book a meeting to learn more.

 

More resources

More regulatory intelligence resources to help you build your regulatory intelligence capability