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QbD Group and Vigintake join forces to advance the automation of pharmacovigilance and safety operations, combining deep regulatory expertise with cutting-edge technology.
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QbD Group & delaware announce a new partnership to help life sciences companies accelerate their digital transformation while ensuring full GxP compliance.
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QbD Group joins ASEBIO, strengthening its commitment to quality, compliance, and safety within the Spanish life sciences sector.
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QbD Group has been awarded the title of Best Pharmacovigilance Service Company at the latest edition of Farmaforum.
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QbD Group welcomes Dr. Diane Fairweather as Division Head Clinical, with 25+ years in global clinical leadership to strengthen and scale the division.
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QbD Group awarded Gold Label as Best Managed Company 2025, marking six consecutive years of recognition for excellence in the life sciences industry.
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Dr. Angeles Escarti-Nebot joins QbD Group as Head of Regulatory Affairs, bringing global regulatory expertise to advance innovation in life sciences.
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Azierta integrates into QbD Group, expanding services and global reach, enhancing client value and employee opportunities in life sciences consultancy.
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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.
WebinarLeveraging 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.
WebinarEarly-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.
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.
White PaperWhat 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.
WebinarJoin 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.
Regulatory UpdateICH 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.
WebinarManage the risk of nitrosamines in the pharmaceutical industry. Watch our webinar on demand and learn about regulation and risk analysis from experts.
WebinarBuilding 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.
WebinarThis 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.
Regulatory UpdateThe 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.
Case StudyLearn how QbD Group helped a biotech CDMO close CAPAs across Quality Assurance, Qualification & Validation, and Software, strengthening GMP compliance and audit readiness.
