Stay ahead in life sciences with expert insights, regulatory updates, and practical guidance.
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 WebinarAdopting AI in life sciences holds enormous potential, but navigating GxP requirements adds real complexity. In this joint session, QbD Group and delaware walk you through how to deploy AI that is trustworthy, validated, and inspection-ready, covering data governance, explainability, and lifecycle management. Building on the first session, this edition dedicates more time to answering your questions, addressing the topics raised by the audience in Session 1, and opening the floor for live debate and discussion.
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Upcoming 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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Upcoming WebinarThis webinar explains why EU market entry requires a fundamentally different approach than you might expect. We'll explore where home-market regulatory logic breaks down in Europe — with a specific focus on clinical evidence expectations, Notified Body interactions, and lifecycle obligations.
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Upcoming WebinarThis webinar is a practical guide for Chinese pharmaceutical manufacturers preparing for Europe. It explains how EU-GMP requirements apply across the manufacturing and supply chain lifecycle, how inspections and certifications influence timelines, and how to build a launch-ready setup that supports smooth QP release and uninterrupted supply.
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White PaperFDA or NMPA approval doesn't mean EU readiness. Learn why home market success often leads to delays under EU MDR, and how to avoid them.
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BlogEntering Europe after FDA approval? Learn how to manage EU and UK regulatory submissions, authority interactions, and submission timelines efficiently.
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BlogPrepare for First-in-Human trials with the right operational framework. Align safety, governance, and clinical execution to meet regulatory expectations.
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BlogEntering the EU market requires more than approval. Discover the pharmacovigilance, quality, and MAH requirements biotechs must prepare before European launch.
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On Demand WebinarJoin Kirsten van Garsse (QbD Group) and Jules Petit (GenDx) as they discuss key regulatory developments and trends in the Companion Diagnostics space, exploring the grey zones and growing pains of CDx co-development between Pharma and IVD manufacturers.
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BlogUtilities such as pharmaceutical water systems and gases are often overlooked in Annex 1 remediation. Discover common compliance gaps and how to mitigate them.
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BlogExtractables and leachables requirements are evolving with draft ICH Q3E. Learn how companies can prepare for future E&L regulatory expectations.
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White PaperUnderstand sponsor responsibilities in IVD clinical performance studies across IVDR, applicable FDA requirements (including IDE where relevant), and ISO 20916, including delegation, CRO roles and combined study models.
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Regulatory UpdateISO 14155:2026, the fourth edition of the international Good Clinical Practice standard for medical device clinical investigations, has been published. It replaces ISO 14155:2020 and sets new requirements for risk management, Clinical Events Committees, Data Monitoring Committees, study design and adverse event reporting.
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BlogExpanding across Europe introduces complex pharmacovigilance requirements. Learn how EU PV systems can scale while integrating national roles and regulatory obligations.
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BlogAI is transforming pharmacovigilance processes from case processing and literature monitoring to signal detection. Discover how AI and NLP can enhance efficiency, compliance, and regulatory intelligence.
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BlogSuccessful MedTech companies treat product development as a lifecycle strategy. Learn why regulatory planning, IP strategy and development must evolve together.
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BlogDeveloping Software as a Medical Device under EU MDR requires clear intended use, risk classification under Rule 11, and compliance with IEC 62304. Learn what SaMD developers need to know.
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