Elsevier launches PharmaPendium AI, designed to support faster and more reliable access to regulatory insights for drug development

The solution transforms how insights are gathered from regulatory data, enabling users to quickly identify critical precedents, anticipate approval issues and avoid costly missteps

LONDON, Sept. 3, 2025 /PRNewswire/ -- Elsevier, a global information and analytics company, today launches PharmaPendium AI, a generative AI assistant for regulatory intelligence in drug development. The solution transforms how regulatory affairs professionals, preclinical and clinical researchers access and apply information from US Food and Drug Administration (FDA) and European Medicines Agency (EMA) regulatory documents.

PharmaPendium AI, layered on top of PharmaPendium, the company's trusted regulatory tool, delivers citation-backed answers to complex regulatory questions in seconds, helping users move faster with greater confidence. It streamlines the discovery and contextualization of actionable insights using retrieval augmented generation (RAG) and natural language processing. Early access users reported time savings of up to 66% per search and review session, potentially resulting in hundreds of hours saved each year.

By accelerating access to regulatory precedent and reviewer commentary, PharmaPendium AI helps pharmaceutical and life sciences companies anticipate regulatory concerns and strengthen evidence-backed planning across the drug development lifecycle. The solution:

• Converts natural language queries into precise instructions to search PharmaPendium's regularly updated corpus of over 5 million pages of FDA approval packages, EMA documents, Advisory Committee transcripts and Meyler's Side Effects of Drugs.
• Supports search and retrieval in multiple languages, enabling the discovery of data across international research teams and facilitating international collaboration.
• Generates answers exclusively from PharmaPendium content, linking directly to the original source documents, minimizing the risk of hallucinations and supporting regulatory-grade fidelity.
• Includes expert human oversight of prompts and response quality, further building trust and transparency.
• Provides answers in multiple formats, including summaries and submission-ready tables. Responses can be aligned with regulatory language and reinforce compliance rationale, helping teams prepare high-quality submissions with increased confidence.

Mirit Eldor, Managing Director, Life Sciences Solutions, Elsevier: "Bringing new medicines to patients quickly depends on timely, well-informed decisions throughout drug development. For regulatory affairs and R&D professionals, finding, extracting and synthesizing regulatory data is vital but can be time-consuming. With PharmaPendium AI, users can access critical insights quickly and apply trusted information to support submissions, risk assessments and experimental design. PharmaPendium AI illustrates Elsevier's commitment to deliver trusted content powered by responsible AI that accelerates innovation in pharmaceutical R&D and helps advance healthcare."

PharmaPendium AI was developed and refined in close collaboration with regulatory and R&D professionals across the pharma industry, and in accordance with Elsevier's Responsible AI Principles and Privacy Principles which prioritize data privacy, security, and transparency. All user interactions are private, with no data used to train external models. This new release is the latest in a series of solutions from Elsevier that help users discover, analyze and synthesize research using trusted content powered by responsible AI.

About Elsevier

Elsevier is a global leader in advanced information and decision support. For over a century, we have been helping advance science and healthcare to advance human progress. We support academic and corporate research communities, doctors, nurses, future healthcare professionals and educators across 170 countries in their vital work. We do this by delivering mission-critical insights and innovative solutions that combine trusted, evidence-based scientific and medical content with cutting-edge AI technologies to help impact makers achieve better outcomes. We champion inclusion and sustainability by embedding these values into our products and culture, working with the communities that we serve. The Elsevier Foundation supports research and health partnerships around the world.

Elsevier is part of RELX, a global provider of information-based analytics and decision tools for professional and business customers. For more information, visit www.elsevier.com and follow us on social media @elsevierconnect.

Media contact
Mathew Pitt-Bailey, Global Communications Director
+44 (0) 7353 890 322
m.pittbailey@elsevier.com

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