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Elsevier Launches PharmaPendium AI

On September 3, 2025, Elsevier, a global leader in information and analytics, announced the launch of PharmaPendium AI, a revolutionary generative AI assistant specifically designed to enhance regulatory intelligence in drug development. This innovative tool is tailored to meet the needs of regulatory affairs professionals and researchers in preclinical and clinical settings, enabling them to quickly access and utilize crucial information drawn from regulatory documents provided by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

PharmaPendium AI marks a significant advancement in how insights are extracted from vast regulatory datasets. It builds upon the existing PharmaPendium tool, which is widely trusted in the industry, and offers users immediate, citation-backed responses to complex regulatory queries. By leveraging advanced technologies like retrieval augmented generation (RAG) and natural language processing, the AI facilitates a faster review process, helping professionals avoid costly errors and mitigating regulatory concerns efficiently.

Early adopters of PharmaPendium AI reported astonishing time savings of up to 66% per search and review session. This efficiency translates to potential annual savings of hundreds of hours, which can be pivotal in the fast-paced environment of pharmaceutical research and development.

Key Features of PharmaPendium AI

PharmaPendium AI provides several cutting-edge features for its users, enhancing both the speed and quality of regulatory interactions:

• - Natural Language Queries: Users can input their questions in plain language, and the AI will convert these inquiries into precise search instructions within PharmaPendium’s continuously updated database of over 5 million pages of regulatory texts, including FDA approval packages and EMA documents.
• - Multilingual Support: The new AI tool allows for inquiries and data retrieval across multiple languages. This is crucial for global research teams, promoting collaboration and data sharing internationally.
• - Regulatory Credibility: All answers provided by the AI are exclusively derived from the PharmaPendium content, linking back to the original source documents. This minimizes the risk of inaccuracies and ensures a high fidelity of information, which is vital in regulatory submissions.
• - Expert Oversight: Each generated response undergoes human review to ensure optimal quality and reliability, fostering user trust and transparency in the information provided.
• - Varied Response Formats: The AI generates responses in several formats, including detailed summaries and submission-ready tables. These can be aligned with regulatory language, thus assisting teams in crafting compliant and effective submissions.

Mirit Eldor, Managing Director of Life Sciences Solutions at Elsevier, stated that: "Bringing new medications to patients swiftly hinges on making timely, well-informed decisions during the drug development process. With PharmaPendium AI, users can access critical insights quickly, which enables them to apply reliable information in their submissions, risk assessments, and experimental designs. This AI solution underscores Elsevier's commitment to leveraging responsible AI to foster innovation in pharmaceutical research and ultimately advance healthcare."

Development and Ethical Considerations

PharmaPendium AI was created through extensive collaboration with regulatory and research professionals within the pharmaceutical industry, adhering to Elsevier’s Responsible AI Principles and Privacy Principles. These guidelines prioritize data privacy, security, and transparency, ensuring all user interactions remain confidential, with no external training data incorporated into the model.

This launch is a part of Elsevier’s ongoing initiative to enhance research experiences using responsible AI technologies. By providing tools that facilitate the discovery, analysis, and synthesis of critical insights, Elsevier continues to support the healthcare community in its quest to deliver better outcomes.

About Elsevier

Elsevier has been a global leader in advanced information and decision support for over a century. It serves diverse sectors, including academic and corporate research communities, health care professionals, and educational institutions across 170 countries. Elsevier's commitment to innovation is evident in its comprehensive solutions that blend trustworthy, evidence-based scientific content with cutting-edge AI technology, thereby empowering its users to achieve impactful results. The company is part of RELX, a global provider of information-based analytics and decision tools for professionals and businesses worldwide. For more information about Elsevier and its offerings, please visit www.elsevier.com and follow them on social media (@elsevierconnect).