Elsevier, a major player in information and analytics, has launched PharmaPendium AI, a generative AI assistant made to help regulatory affairs professionals and clinical researchers find and understand guidance from organizations like the FDA and EMA. This AI tool is built on the foundation of Elsevier’s well-known PharmaPendium platform and provides fast, reliable, and source-cited responses to complex questions. It uses advanced technologies such as natural language processing and retrieval augmented generation to make regulatory research more efficient and support faster decision-making. Early users have noted saving up to 66% of their time during research and review tasks.
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PharmaPendium AI lets users ask regulatory questions in everyday language and gets accurate answers directly from a massive database containing millions of pages of regulatory documents. These include FDA approval files, EMA evaluations, advisory meeting records, and drug safety information. The tool supports multiple languages, helping teams work together more effectively around the world. Each response is tied to the original source document, reducing the chance of errors and keeping a high level of trust.
In addition to quick answers, PharmaPendium AI provides outputs in different formats, such as brief summaries or tables ready for submissions. These features are designed to help produce high-quality regulatory documents by following standard industry language and making the documentation clearer. The AI tool assists researchers and regulatory teams in predicting potential questions from regulatory agencies, building stronger evidence, and making better plans throughout the drug development process.
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Mirit Eldor, Managing Director of Life Sciences Solutions at Elsevier, said that getting new treatments to patients relies on informed choices and quick access to regulatory data. She highlighted that PharmaPendium AI helps professionals find and use important information quickly, cutting down on manual research time and boosting confidence in submission plans. This tool shows Elsevier’s dedication to blending reliable scientific content with responsible AI development.
PharmaPendium AI was developed with feedback from regulatory and R&D experts and is aligned with Elsevier’s Responsible AI and Privacy Principles. User interactions are kept confidential, and no data is used to train other AI models. The release of this tool is part of Elsevier’s wider effort to support healthcare innovation by combining scientific knowledge with state-of-the-art AI technology.
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