Clarivate's AI Agent Aims to Tame Pharma's Regulatory Chaos

LONDON, UK – December 04, 2025

In a significant move to arm the life sciences industry against its most persistent challenge—regulatory complexity—intelligence provider Clarivate Plc has officially launched its Cortellis Regulatory Intelligence AI Assistant. The new tool, powered by what the company calls “agentic AI,” promises to move beyond simple information retrieval and fundamentally reshape how pharmaceutical and medical device companies manage safety and compliance.

Following a successful beta program with industry heavyweights like Bayer and Moderna, the assistant is now available to all Cortellis customers. It represents a critical step in the application of advanced artificial intelligence to one of the most data-intensive and high-stakes sectors of the global economy. Unlike conventional AI tools that respond to direct queries, this new generation of agentic AI is designed to understand context, perform multi-step tasks, and deliver synthesized, actionable insights, effectively acting as a tireless digital partner for overburdened regulatory teams.

Beyond the Chatbot: The Dawn of Agentic AI

The term “agentic AI” marks a pivotal evolution from the generative AI chatbots that have captured public imagination. While those tools excel at generating text or code based on a prompt, an AI agent can proactively plan, reason, and execute complex workflows to achieve a goal. For the life sciences industry, this distinction is crucial. Navigating the regulatory pathway for a new drug is not a single question but a cascade of interconnected challenges involving thousands of pages of guidance documents across multiple jurisdictions.

The Cortellis AI Assistant is engineered to tackle this complexity head-on. Its core functionalities demonstrate a clear departure from basic search. The system allows users to ask complex questions in natural language and receive context-aware, cited answers that build on previous conversations. This ability to reference the source material is a critical feature for an industry where traceability and validation are non-negotiable.

Furthermore, the tool can summarize dense regulatory documents in seconds, offering customized outputs from brief takeaways to in-depth analyses. Perhaps its most powerful feature is the ability to compare different document versions, such as draft and final guidance from agencies like the FDA. This task, which can take a human expert hours of painstaking manual review, can now be completed almost instantly, flagging key changes and accelerating the decision-making process. These capabilities, combined with multilingual support, aim to transform regulatory intelligence from a reactive search-and-find exercise into a proactive strategic function.

Taming a Labyrinth of Global Regulations

The launch arrives at a time when the need for such a tool has never been more acute. The global regulatory landscape for life sciences is a constantly shifting labyrinth of national requirements, updated guidance, and evolving standards. For companies operating internationally, maintaining compliance is a monumental and costly undertaking. The sheer volume and intricacy of the data make manual processing not only inefficient but also prone to risk.

This is the core pain point Clarivate aims to solve. By leveraging its repository of over 30 years of curated regulatory data, the AI assistant provides a powerful layer of intelligence to help teams cut through the noise. The feedback from early adopters underscores this value proposition. Wendy Lara, a Senior Manager at Bayer, noted that the tool “made it significantly faster for us to find the right documents without the need for complex/advanced filtering.” She emphasized that it provides “valuable foundational guidance, allowing our subject matter experts to focus their time on in-depth document review rather than document searches.”

This sentiment was echoed by Janeen Skutnik-Wilkinson, a Director at Moderna, who participated in the beta testing. She highlighted the potential for significant time and resource savings, which would speed up internal intelligence work. The goal is not to replace human experts, but to augment them, freeing them from tedious, low-value tasks to focus on high-level strategy, risk assessment, and interpretation where human judgment is irreplaceable.

The Competitive Chessboard of Life Sciences Tech

Clarivate's move is a calculated play in the increasingly competitive RegTech (Regulatory Technology) market. The company is not alone in recognizing the opportunity to apply AI in this space. Cloud software giant Veeva Systems has a dominant position with its end-to-end platform for life sciences, while analytics powerhouse IQVIA integrates AI across its vast clinical and commercial data offerings. Even Thomson Reuters, from which Clarivate was spun out in 2016, is making its own push into agentic AI for legal and tax professionals, signaling a broader industry trend.

Against this backdrop, Clarivate is leveraging its unique assets: a deep, specialized dataset in regulatory intelligence and a long-standing reputation, with 88% of the top 25 pharmaceutical companies already using its Cortellis platform. The launch of the AI assistant is a defensive and offensive strategy—it shores up its existing client base by adding significant value while simultaneously creating a compelling differentiator to attract new customers.

The company’s broader AI strategy, underscored by its March 2025 acquisition of MotionHall, a vertical AI start-up for life sciences, shows a clear commitment to building and buying its way to a leadership position. By developing a core AI platform that also powers its Web of Science research tools, Clarivate is creating an ecosystem of intelligent solutions that can be leveraged across the entire product development lifecycle, from early-stage research to post-market surveillance.

As AI continues to mature, the ability to combine advanced algorithms with proprietary, high-quality data will be the key determinant of success. In launching the Cortellis Regulatory Intelligence AI Assistant, Clarivate has made a clear statement that it intends to lead that charge in the life sciences arena, betting that its deep domain expertise is the critical ingredient that will turn the promise of AI into tangible business results. This human-AI partnership model, built on a foundation of trust and explainability, may well set the new standard for how industries navigate complexity in the 21st century.