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    QbD INSIGHTS

    Edition #47 · Jan 2026

    Bi-weekly

    Featured

    EU MDR Transition: What Manufacturers Need to Know Before the 2027 Deadline

    The latest guidance from the European Commission clarifies key requirements for legacy devices…

    IVDR Update: Notified Body capacity report, current state and projections

    Industry Trend: AI-driven pharmacovigilance, regulatory expectations in 2026

    Upcoming: Free webinar on Post-Market Surveillance best practices, Feb 12

    QbD INSIGHTS

    Edition #46 · Dec 2025

    Bi-weekly

    Featured

    CDx & Companion Diagnostics: Navigating the Evolving EU Regulatory Landscape

    As precision medicine advances, companion diagnostic regulation is catching up. Here's your roadmap…

    White Paper: Quality by Design in pharmaceutical development, 2025 edition

    Compliance Alert: EMA updates GMP Annex 1, key changes for sterile manufacturing

    Case Study: How we helped a biotech startup achieve EU market launch in 9 months

    RECENT EDITIONS

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