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QbD Group awarded Platinum label as Best Managed Company 2026, marking seven consecutive years of recognition for excellence in the life sciences industry.
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At QbD Group, we are joining forces with Vigintake to support the evolution of pharmacovigilance operations through intelligent automation and innovative digital solutions, combining regulatory expertise, quality systems, and advanced technology.
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QbD Group today announces the acquisition of Rescop, a specialist in GxP compliance, computer system validation, and validation software for the life sciences industry.
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QbD Group has been recognized with the AEFI Award for Best Publication of 2025 for the article "Pharmacovigilance in innovative therapies: Regulatory and clinical challenges," authored by Almudena del Castillo, Head of Global Vigilance Division and Country Manager Spain.
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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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White PaperA comprehensive overview of the state of the art in Advanced Therapy Medicinal Products (ATMPs) as of June 2026 — covering EU regulation, cutting-edge manufacturing, evolving quality standards, and the business strategies shaping the future of gene, cell, and tissue therapies.
Case StudyDiscover how QbD Group helped Techdow Pharmaceutical, a leading Chinese exporter of complex biologicals, achieve EU GMP certification, Marketing Authorisation, and full commercialisation across Europe.
Case StudyDiscover how QbD Group helped Henlius, a China-based biopharmaceutical company, achieve full regulatory compliance and launch in the EU within 3 months of Marketing Authorisation grant.
White PaperAs pharma SMEs and biotechs grow, pharmacovigilance systems that once worked well can quickly become a bottleneck. This white paper breaks down how to build a pharmacovigilance (PV) setup that scales with your business, without losing compliance or control.
Case StudyDiscover how QbD Group helped a Spanish pharmaceutical company develop a scalable pharmacovigilance model supporting international growth and regulatory compliance.
Case StudyDiscover how QbD Group helped a Chinese biopharmaceutical company build a scalable global pharmacovigilance framework for EU entry and worldwide expansion.
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.
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.
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.
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.
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.
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.
