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QbD INSIGHTS
Edition #47 · Jan 2026
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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
推荐
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
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