Stay ahead in life sciences with expert insights, regulatory updates, and practical guidance.
Upcoming WebinarDescubre el enfoque BxP para alinear BPL y BPM, cerrar brechas técnicas entre laboratorio y planta, y blindar el cumplimiento ante hallazgos críticos en auditorías regulatorias.
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Upcoming WebinarUnderstand how to translate ERA regulatory expectations into a robust, science-based and submission-ready approach. Learn how to avoid common pitfalls, optimize data requirements and build a defensible Environmental Risk Assessment aligned with current regulatory expectations.
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Upcoming WebinarIn this 60-minute session, Egbert Smit (CEO of MLA Diagnostics) and Annelies Rotthier (QbD Group) unpack the clinical evidence decisions that trip up oncology diagnostic startups — and how to get them right the first time.
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Upcoming WebinarDeploying AI in a GxP-regulated environment comes with real compliance challenges. In this joint session, QbD Group and delaware cover how to implement AI that is validated, traceable, and inspection-ready. Building on Session 1, this edition opens more time for your questions and live discussion.
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Case StudyDiscover how QbD Group helped a Spanish pharmaceutical company develop a scalable pharmacovigilance model supporting international growth and regulatory compliance.
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Case StudyDiscover how QbD Group helped a Chinese biopharmaceutical company build a scalable global pharmacovigilance framework for EU entry and worldwide expansion.
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BlogDiscover the practical challenges of Environmental Risk Assessments (ERAs) in pharma, from toxicology input to data consistency and lifecycle management.
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BlogDiscover why governance and role clarity are critical in combined drug-diagnostic studies under the CTR and IVDR.
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BlogDiscover why early collaboration between pharma sponsors and IVD partners is critical for successful companion diagnostic development under the IVDR.
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BlogDiscover why IVDR performance study submissions remain fragmented across Europe and how regulatory differences impact timelines and study strategy.
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BlogThinking Article 5(5) is the easy route under the IVDR? Discover the hidden obligations and risks of in-house devices.
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BlogDiscover when an assay used in a clinical trial falls under the IVDR and what this means for timelines, compliance, and study strategy.
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On Demand WebinarThis webinar translates the revised EU GMP Annex 1 requirements into structured, practical actions across sterile manufacturing environments. Learn how to assess implementation challenges, prioritize remediation efforts and strengthen sustainable compliance.
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BlogDiscover a 7-phase AI/ML compliance framework for life sciences, covering data governance, validation, and post-launch monitoring under GxP.
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BlogPharma is still figuring out AI validation. MedTech already solved it. Learn what to copy from MedTech's proven playbook to ensure GxP compliance and real-world impact.
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BlogCE marking isn't just clinical and regulatory. Discover the hidden operational hurdles that delay EU market entry.
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BlogDiscover why clinical strategy, not data, is the real bottleneck for EU MDR market access and how to align regulatory and clinical decisions.
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BlogDiscover what non-EU manufacturers get wrong about clinical evidence under the EU MDR, from CER requirements to PMCF and data reuse.
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