AI-Powered Regulatory Intelligence: Tackling Data Overload with Precision and Relevance

Introduction: tackling information overload in regulatory affairs 

 Regulatory professionals face an overwhelming flow of fragmented data: guidelines, publications, updates, safety signals, and emerging risks spread across public, private, and niche sources. 

Manual monitoring is time-consuming and risks delays or missed signals. Even expert documents may rely on outdated or incomplete information. 

Artificial Intelligence (AI) accelerates regulatory data processing, automation, and decision support,1,2 streamlining tasks like dossier preparation and compliance monitoring to reduce time to market. However, applying AI to domain-specific regulatory contexts remains challenging. 

Our ambition: 

Build a trusted, integrated regulatory companion that unifies fragmented data into a context-aware knowledge base, processes information in real-time, and delivers expert-level insights at the speed of decision-making, empowering regulatory professionals with timely, actionable intelligence while reducing noise. 

Methodology: Building an AI-native regulatory intelligence ecosystem 

 A structured, multi-layered approach to deliver trusted, dynamic regulatory insights: 

1. Data Understanding, Structuring, and Connectivity 

• Map and classify diverse data sources (public, private, and niche). 

• Build seamless access pathways and establish a unified data model for structured and unstructured information. 

2. Processor Development 

• Deploy classifiers, scrapers, universal translators, and automation tools for data extraction and normalization. 

3. AI Data Hub Creation 

• Centralize processed data streams for advanced fusion and contextualization. 

4. Derivation and Context Generation 

• Leverage RAG, context retrieval, and LLM technologies to create enriched, derived insights. 

5. Applicative Layer for End-Users 

• Provide an accessible web-based SaaS platform with filters, dashboards, automated reports, chat, and newsletters for real-time user interaction. 

Building our framework vision 

End-to-End Intelligent Workflow 

Our framework combines automated data capture with advanced AI processing, ensuring high relevance and context-aware outputs: 

• Comprehensive Data Integration: Structured and unstructured data from public and private sources. 

• AI-powered processing: LLM, NER, universal translators, classifiers, and orchestrated AI agents transform raw data into meaningful insights. 

• Real-Time Signal Detection: Early identification of regulatory changes, safety concerns, and emerging trends through continuous monitoring and pattern recognition. 

• User Interaction: Experts interact with dashboards and reports, providing feedback loops that continuously refine the system. 

Guiding Principle: Dimensionality reduction without insight loss — simplifying complexity while preserving essential information. 

Benefits 

• Speed: Automated processing drastically reduces time to insight. 

• Relevance: Signal prioritization filters out noise, ensuring critical alerts reach users first. 

• Coverage: Access to both mainstream and niche data sources for 360° visibility. 

• Efficiency: Reduces manual workload, allowing experts to focus on interpretation and decision-making. 

• Compliance-Ready: Ensures regulatory teams are always aligned with the latest guidelines and updates. 

Future Vision

Today, our system is already operational with key processors in place:

Universal Translator for multilingual regulatory affairs, API integration, Scrapper, Document Extractor, AI Classifier, and more.

Our ambition is to build upon this solid foundation to realize the full vision presented in our framework:

A unified, intelligent regulatory ecosystem that seamlessly connects diverse data sources, processes information in real-time, and delivers actionable insights directly to users, enabling smarter, faster regulatory decision-making.

“We Know the Regulatory Affairs Landscape and We Innovate Within It”

As a trusted partner in life sciences consulting, at PLG, we have a deep understanding of the regulatory landscape across the entire product lifecycle, from early development to post-market oversight. Whether it’s ensuring compliance, maintaining data traceability, supporting pharmacovigilance, or managing global suppliers, our teams are equipped to handle the complexities our clients face.

Working with a wide range of clients gives us a comprehensive view of industry-wide challenges and unmet needs. This broad perspective allows us to identify patterns and pain points, and more importantly, to act on them.

That’s why we’ve built a dedicated Digital Research and Innovation team.

Their mission: to dive deep into the state of the art and translate cutting-edge technologies into tailor-made digital applications. These solutions are crafted to address the specific challenges of our field, not with generic tools, but with the most precise, effective approaches for each case.

Innovation in Action

For example, in partnership with a client, we co-designed an AI-powered tool for local literature monitoring in pharmacovigilance. The result? A domain-specific AI classifier that boosts compliance, speeds up signal detection, and significantly reduces manual workload.

Our Differentiator

We don’t just offer consulting, we enable our experts with intelligent, high-value tools that amplify their impact. By co-creating with our clients and leveraging innovation grounded in domain expertise, we deliver solutions that stand apart. This is our edge in a crowded market: deep knowledge, empowered by precision-built technology.”

References

1. Ajmal, C.S., et al., AAPS J 27, 22 (2025).
2. Mayer, M. et al., Ther Innov Regul Sci 53, 759–766 (2019).

Authors:

Melissa Bou Jaoudeh – Innovation Product Development Officer

Hocine Kadi – Solution Architect Officer

Florian Pereme – Digital Innovation Lead – Research & Innovation

ProductLife Group