Knowledge Center | QbD Group

Entering the European MedTech Market: Why One Approval Doesn't Fit All

Regulatory AffairsApr 29, 2026

Building on QbD Group's Landing in Europe MedTech whitepaper, this 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.

Upcoming Webinar

AI in Life Sciences

Software Solutions & ServicesMar 19, 2026

Leveraging AI in life sciences is powerful, but also complex under GxP. In this joint webinar, QbD Group and delaware show how to implement AI in a trustworthy, validated, and inspection-ready way, with the right approach to data, explainability, and lifecycle management.

Upcoming Webinar

From Strategy to First-in-Human: A Practical Roadmap for Biotech Development

Regulatory AffairsMar 18, 2026

Early-stage biotech teams often struggle to translate scientific innovation into first-in-human readiness. This webinar provides practical guidance to help teams build a clear, scalable development pathway that aligns regulatory strategy, CMC, quality, and clinical planning. Reducing risk, avoiding delays, and staying inspection-ready without overbuilding internal structures.

Blog

Scaling Pharmacovigilance Across Europe: Managing Local Requirements Without Losing Control

PharmacovigilanceApr 3, 2026 6 min

Expanding across Europe introduces complex pharmacovigilance requirements. Learn how EU PV systems can scale while integrating national roles and regulatory obligations.

White Paper

Annex 1 Compliance Signals from FDA Warning Letters

Quality AssuranceMar 13, 2026 1 min

What do 230 FDA warning letters reveal about recurring sterile manufacturing deficiencies? This white paper analyses inspection findings from 2023–2025 and maps them to EU GMP Annex 1 expectations, revealing where manufacturers most frequently fall short of sustainable compliance.

On Demand Webinar

Cleaning Validation Based on PDEs

Qualification & ValidationMar 11, 2026

Join our webinar and discover how to apply PDEs (Permitted Daily Exposures) to minimize critical risks and ensure regulatory compliance, combining science, statistics, and advanced digital tools. Learn from experts how to transform cleaning validation into a safer, more efficient, and predictable process.

Watch now

Blog

FDA to EU/UK Submission Strategy: Pre-Submission Optimization for US Biotechs

Regulatory AffairsMar 4, 2026 4 min

US biotech expanding to Europe? Learn how to convert FDA submission packages into EU and UK dossiers efficiently and avoid costly pre-submission rework.

Blog

People as a Critical Risk Factor in Annex 1: Personnel Gowning, Training and Aseptic Behaviour

Qualification & ValidationMar 4, 2026 4 min

Annex 1 places strong emphasis on personnel behaviour in sterile manufacturing. Learn how gowning, training, and aseptic discipline influence contamination control.

Blog

EMA Scientific Advice for Biotech Startups: Getting Actionable Regulatory Guidance

Regulatory AffairsMar 4, 2026 4 min

Learn how biotech startups can use EMA Scientific Advice to test development strategy, structure regulatory questions and reduce risk before CTA and first-in-human trials.

Regulatory Update

ICH E2D(R1) – New Expectations for ODCS, PSPs, MRPs & Digital Platforms

Regulatory AffairsMar 4, 2026 3 min

ICH E2D(R1) introduces new expectations for ODCS, PSPs, MRPs and digital platforms. Learn what MAHs must implement by 18 March 2026 to ensure pharmacovigilance compliance.

On Demand Webinar

Nitrosamine Risk Assessment: Adapting to the Latest Regulatory Expectations

ToxicologyMar 4, 2026

Manage the risk of nitrosamines in the pharmaceutical industry. Watch our webinar on demand and learn about regulation and risk analysis from experts.

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On Demand Webinar

From R&D to market: IP and regulatory strategy across the product life cycle

Regulatory AffairsFeb 26, 2026

This webinar follows the stages of a product’s life cycle, explaining how structured, science-based development and intellectual property considerations support regulatory alignment and long-term value creation.

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Regulatory Update

EMA Framework for the Qualification of Non-Mutagenic Impurities

Regulatory AffairsFeb 25, 2026 2 min

The European Medicines Agency (EMA) has adopted a Reflection Paper on the Qualification of Non-Mutagenic Impurities (EMA/CHMP/4299/2026), introducing a new scientific framework for the safety assessment of non-mutagenic impurities in medicinal products.

Blog

Annex 15 Revision: What API Manufacturers Must Prepare for Now

Qualification & ValidationFeb 25, 2026 3 min

The Annex 15 revision will make qualification and validation mandatory for API manufacturers. Learn how to prepare lifecycle validation and inspection readiness.

Blog

Planning EU Expansion: What US Biotechs Must Get Right From Day One

Regulatory AffairsFeb 18, 2026 4 min

Planning EU and UK expansion as a US biotech? Learn which regulatory, clinical and operational decisions matter from day one.

Blog

Residual Solvent Testing in Pharmaceuticals: From Process to Patient

Lab ServicesFeb 18, 2026 3 min

Residual solvent testing is essential to patient safety and regulatory compliance. Learn how GC-FID and GC-MS support ICH Q3C compliance in pharmaceutical manufacturing.

Blog

Scaling PV Governance in Europe: Maintaining Oversight as Organizations Grow

PharmacovigilanceFeb 13, 2026 4 min

As European SMEs and biotechs expand, PV governance must scale to maintain EU-QPPV oversight and inspection readiness. Learn how to build a scalable pharmacovigilance system.

Blog

Cleanrooms, Isolators and RABS: Meeting Annex 1 Expectations for Modern Aseptic Manufacturing

Qualification & ValidationFeb 13, 2026 5 min

Learn how Annex 1 expectations for cleanrooms, isolators and RABS shape modern aseptic manufacturing. Practical guidance on barrier strategy, airflow visualization and contamination control.