Regulatory intelligence in the pharmaceutical industry: What you need to know

The professional association RAPS (Regulatory Affairs Professionals Society) describes regulatory intelligence as a systematic process of gathering, reviewing, analyzing and communicating regulatory information. That information is typically publicly available (from regulators, guidances, agency websites, legislation, public filings, regulatory news) and may come from a variety of global health authorities.

The goal of regulatory intelligence is not just passive gathering, but to transform raw regulatory data into actionable insights that support strategic and operational decision-making across the pharmaceutical product lifecycle (development, submissions, post-market). Regulatory intelligence is a way of managing available evidence by screening (or monitoring, or surveilling), analyzing and communicating information to support regulatory decision-making.

RI is used by regulatory affairs professionals, but also by other cross-functional stakeholders: product development, GxP compliance, drug safety, quality assurance, regulatory strategy, senior management, and sometimes business/risk-assessment teams.

Key regulatory agencies pharmaceutical companies monitor

Pharmaceutical companies must monitor several key regulatory agencies worldwide, including:

These agencies influence drug sales, where a drug can be sold, development strategies, clinical trial design, safety monitoring and post-marketing commitments (which directly affects timelines, cost, and global launch sequencing), pricing, safety monitoring, and innovation incentives. As regulations evolve, pharmaceutical companies must adopt proactive RI practices.

Why is regulatory intelligence important for pharma

RI is crucial in navigating the complex regulatory landscape. RI is at the heart of every well-informed regulatory decision in pharmaceuticals today. As the regulatory environment becomes more complex and global, with more regulatory authorities, diverse product types and rapidly evolving guidances, RI has become strategically vital.

It supports compliance, reduces risks, and enhances competitive intelligence. Key benefits include:

• Navigating complexity: Compliance with evolving laws and guidelines from various agencies.
• Risk mitigation: Early warnings of regulatory changes to avoid costly mistakes.
• Strategic decision-making: Insights that guide decisions throughout the product lifecycle.

Core components of pharmaceutical regulatory intelligence

The RI process includes:

1. Surveillance: Monitoring global agencies and competitors.
2. Filtering: Prioritizing relevant information.
3. Analysis: Interpreting impacts.
4. Communication: Sharing findings with stakeholders.
5. Action: Informing strategy and decisions.

At our recent Regulatory Forum ‘Transforming Regulatory Intelligence into Action’ Chris Whalley, regulatory intelligence leader at Pfizer, presented his own Regulatory Intelligence Framework which unifies various teams under a common understanding of regulatory intelligence. It comprises four key capabilities:

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

Each capability involves people, processes, and technology, forming a comprehensive model for regulatory intelligence.

Regulatory intelligence requirements across the lifecycle of a pharmaceutical product

RI is essential at various stages of a pharmaceutical product’s lifecycle:

Benefits of regulatory intelligence in pharma

Faster time to market

• Optimal regulatory pathways
• Streamlined clinical trials
• Agile decision-making

Ensured global compliance and risk mitigation

• Reduced compliance costs
• Enhanced pharmacovigilance

Strategic decision-making and competitive advantage

• Informed R&D pipeline
• Global expansion opportunities

Increased operational efficiency

• Resource optimization
• Standardized documentation

Common regulatory challenges facing pharmaceutical companies

• Rising complexity: Increased guidance and updates create tracking challenges.
• Manual methods: Reliance on outdated tools leads to inefficiencies.
• Lack of visibility: Difficulty prioritizing changes affects strategic planning.
• Delayed awareness: Critical updates may not reach relevant teams in time.
• Blind spots: Local developments can be overlooked, increasing compliance risks.
• Disconnected workflows: Siloed tools hinder effective collaboration.

How Infodesk helps pharmaceutical companies overcome regulatory challenges

Infodesk helped one global pharmaceutical company to access critical insights, empowering the team to overcome the challenges of information overload. This reduced the time spent searching for insights by 80%, enabling the team to operate more efficiently and effectively. Already the client is looking to broaden the topics included, covering other aspects of marketed and pipeline drug intelligence. See case study.

Infodesk helped another global pharmaceutical company to save 53% of time spent on monitoring and analysis of regulatory intelligence, which saved senior stakeholders more than three hours per week hours per week accessing regulatory insights for decision-making. Overall this enabled the business to reallocate highly skilled, expensive resources to higher value tasks and strategic initiatives. Read case study.

Start monitoring and actioning regulatory changes with Infodesk

Infodesk is purpose-built for pharmaceutical companies facing regulatory challenges. It centralizes intelligence, monitors updates, and integrates insights into workflows, helping teams respond quickly and confidently to regulatory developments.

With the volume and complexity of regulatory activity increasing, Infodesk gives pharmaceutical companies the tools to stay informed and respond with confidence.

• Stay on top of every change, defend every decision.
• Monitor global policy, guidance, and enforcement updates in one place.
• Cut manual effort with curated, contextualized intelligence.
• Route updates to relevant teams without delays.
• Maintain a clear, auditable trail for every regulatory response.
• Reduce blind spots.
• Understand local implications of global regulations.
• Share intelligence across regions and teams.
• Ensure traceability and defensibility of all compliance actions.

Learn more about how Infodesk helps solve regulatory problems with the regulatory intelligence solution and the regulatory workflow solution.