Biologit

Biologit is a technology company focused exclusively on literature monitoring for pharmacovigilance (PV). Its platform is designed to consolidate global and local literature sources into a single validated environment, enabling PV teams to monitor scientific literature more efficiently, accurately, and at scale. The company was co-founded by a trained immunologist and PV professional alongside an engineering leader with experience at Amazon and Oracle, and serves clients across more than 170 countries, including top-25 pharmaceutical companies, contract research organisations (CROs), and emerging biotechs.

Unlike general-purpose tools adapted for PV use, Biologit describes its platform as purpose-built for literature monitoring from the ground up, with compliance, auditability, and regulatory transparency built in from the start. The platform incorporates AI and automation across the full literature monitoring workflow, covering sources ranging from global databases to local print publications, and supports machine translation of local-language sources.

Core Platform Capabilities

• Comprehensive source coverage: Monitors global databases, local sources, subscription-based publications, websites, and print materials within a single platform.
• Proprietary auditable AI: Uses AI that is transparent and auditable, with no black-box processing, supporting a fully traceable audit trail.
• Machine translation: Translates local-language sources instantly to support monitoring across multiple regions and languages.
• Scalable workflows: Designed to expand across products, teams, and markets as organisational needs grow.
• Integrations: Connects with existing PV and safety tools within an organisation's technology stack.

Compliance and Regulatory Alignment

• The platform is described as GxP-aligned and built in accordance with GAMP guidelines.
• Compliant with 21 CFR Part 11 requirements for electronic records and audit trails.
• Aligned with the EU AI Act, reflecting the company's approach to regulatory-grade AI transparency.
• Provides a 100% traceable audit trail to support inspection readiness.

Who Biologit Serves

• Large pharmaceutical companies: Supports streamlining of literature monitoring operations and scaling across global portfolios.
• CROs and PV service providers: Enables consistent, high-quality monitoring across multiple client programmes.
• Biotech and mid-size pharma: Provides access to enterprise-grade technology regardless of whether an internal PV team is in place.

Leadership Team

• Nicole Baker, PhD – CEO and Co-Founder: A trained immunologist with over 25 years of experience across pharma, CROs, regulators, and research. Has held roles including EEA QPPV and RPPV, and has led Biologit from inception to global adoption.
• Bruno Ohana, PhD – CTO and Co-Founder: An engineer with a 20-year career spanning cloud infrastructure, fintech, healthtech, and AI. Previously held senior roles at Amazon and Oracle, and leads the design and development of the Biologit platform.
• Jean Redmond, PhD – COO: Holds a PhD in Neuroscience from the University of Cambridge and brings over a decade of experience in consulting, general management, and life sciences strategy, including senior roles at IQVIA. Leads strategy and operations at Biologit.

Resources and Community

• Biologit maintains a resource hub offering whitepapers, webinars, use cases, and feature updates aimed at PV professionals.
• Content covers developments in pharmacovigilance, AI, and literature monitoring practices.

Biologit positions itself as a specialist rather than a generalist vendor, with literature monitoring described as its sole focus. The platform has been reported by users to reduce literature monitoring effort by 50 to 60 percent based on time and motion studies, and has been adopted as a primary literature assessment tool by PV teams at global organisations.