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Centralized SmPC with AI-powered Pharmacovigilance Workflows

January 2, 2024

LONDON, January 03, 2024 – PubHive Ltd., a leading provider of AI-powered scientific literature & safety information workflows, today announced the launch of its groundbreaking centralized SmPC (Summary of Product Characteristics) management with AI-powered pharmacovigilance workflows  for life science companies, CROs (Clinical Research Organizations) and their pharmacovigilance and drug safety divisions. This groundbreaking solution simplifies compliance, streamlines processes, and empowers pharmacovigilance teams to work smarter, faster, and more effectively.

Say goodbye to siloed information and manual processes. PubHive's unified platform consolidates all SmPC data and documents into a single source of truth, ensuring consistency and accessibility across teams and locations. AI-powered features automate tedious tasks like document analysis and version control, freeing up PV experts to focus on high-value activities like signal detection and risk assessment.

Key benefits of Centralized SmPC and AI-powered Pharmacovigilance Workflows:

  • Centralized SmPC Management: PubHive provides a centralized repository for SmPCs, making it easy to access, update, and distribute this critical documentation. Say goodbye to scattered and outdated SmPCs.
  • AI-powered Pharmacovigilance: Harness the potential of artificial intelligence to enhance pharmacovigilance efforts. PubHive's AI algorithms can analyse vast amounts of data, helping to detect adverse events, identify trends, and streamline reporting.
  • Compliance and Efficiency: Stay compliant with regulatory requirements effortlessly. PubHive's automated workflows ensure that your pharmacovigilance processes are efficient, accurate, and in line with industry standards.
  • Collaboration and Communication: Foster collaboration within your organization and with external stakeholders. PubHive enables seamless sharing of information and insights, improving decision-making and patient safety.
  • Real-time Alerts and Notifications: Receive real-time alerts on critical pharmacovigilance events. PubHive keeps you informed and proactive in addressing potential issues.
  • Customizable Workflows: Create standardized research pathways tailored to specific PV Workflow for ICSR, Signal and Aggregate Safety Reporting. This customization ensures users can access the resources and data tailored to their workflow requirements.

 Transforming Pharmacovigilance:

“Traditionally, pharmacovigilance has been plagued by siloed data, manual processes, and time-consuming workflows,” says Raj Vaghela, CEO at PubHive. “By providing a single platform, centralized SmPCs and AI-powered Pharmacovigilance workflows break down these barriers, empowering pharmacovigilance teams to work proactively, efficiently, and with greater confidence. This is not just about compliance; it’s about building a safer future for patients.”

Benefits for Life Science Companies and CROs:

  • Reduced costs and increased efficiency through automation and streamlined processes.
  • Improved data visibility and insights for faster risk identification and mitigation.
  • Enhanced regulatory compliance and reduced risk of penalties.
  • Improved collaboration and communication within and across teams.
  • Empowered pharmacovigilance teams to focus on strategic activities and patient safety.

PubHive’s centralized SmPC and AI-powered workflows are changing the game for pharmacovigilance. By automating tasks, enhancing insights, and streamlining compliance, PubHive empowers Life Science companies and CROs to deliver safer medicines and improve patient outcomes.

PubHive is committed to providing innovative solutions that drive efficiency, collaboration, and productivity within the life science industry. For more information about PubHive Navigator and to explore its capabilities, please visit the PubHive website at


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About PubHive

PubHive Ltd. is a cloud-based software company with a mission to make healthier scientific literature and safety workflows for life science companies across all stages of the commercialization lifecycle – from discovery to post-market. PubHive Navigator, the company’s scientific workflow management platform, optimizes existing business processes and automates repetitive work for teams in regulatory and medical affairs, research and developmentdrug safetypharmacovigilance, medical devices, CER/PMCF, medical communication/writing, library, information managementdocument delivery, literature monitoring & reporting and other divisions. Powered by a proprietary Omni-Loop Artificial Intelligence (AI)™ engine, PubHive Navigator is the only 'fit for purpose' one-stop enterprise scientific workflow automation platform today, distinguishing itself through flexible end-to-end workstreams and intuitive interfaces that make literature handling quick and easy.