What QbD Group does

QbD Group is a privately held Belgian life sciences consulting firm founded in 2011 by Bart Van Acker, headquartered in Wilrijk (Antwerp) and operating 11+ offices across Belgium, the Netherlands, Spain, Poland, the UK, Switzerland, Austria, Colombia, and the US with 700+ in-house professionals. The firm delivers integrated regulatory affairs, clinical trial, qualification and validation, quality assurance, software solutions, pharmacovigilance, toxicology, and audit services to pharmaceutical, biotechnology, medical device, IVD, companion diagnostics, combination product, and medical device software companies across the full lifecycle from idea to patient. The firm operates a multi-subsidiary structure including QbD IVD | Qarad (IVD regulatory affairs), Quercus (GMP-certified contract lab), Scilife (SaaS quality management platform), Simabs (CDMO for monoclonal antibodies), SciencePharma (Polish pharma consulting), and Rescop (computer system validation).

The firm's business model is overwhelmingly professional services and project-based consulting, complemented by SaaS subscription revenue through Scilife and CDMO income from Simabs. Go-to-market is enterprise field sales delivered through 11+ regional offices, with a particular emphasis on positioning the firm as a "gateway to the EU" for non-EU life sciences clients needing MDR/IVDR compliance and market entry support. Pricing is quote-driven with no public rate cards, and the firm holds ISO 13485:2016, ISO/IEC 27001:2022, and GMP certifications as credibility markers. Demand generation is content-led through a knowledge center of 509+ resources, industry event presence (CPHI, Medica, TOPRA, ESMO), and seven consecutive years of Deloitte Platinum Best Managed Company recognition. Technology is centered on the Scilife SaaS QMS platform, with AI capabilities positioned primarily through partnerships (FormlyAI, Timeseer, Vigintake, delaware) rather than proprietary models.

Name

QbD Group

Legal name

QbD Group

Website

https://qbdgroup.com

Company type

Private

Founded year

2011

Operating status

Operating

Headcount range

501–1,000 employees

Short description

QbD Group is a privately held Belgian life sciences consulting firm with 700+ in-house specialists across 11+ European offices, delivering regulatory affairs, clinical, quality assurance, validation, and software services to pharma, biotech, medical device, and IVD companies worldwide.

Ownership category

akta.pro rank

Product category

Life Sciences Regulatory Consulting

NAICS

Management Consulting Services (54161), Other Scientific and Technical Consulting Services (54169), Research and Development in the Physical, Engineering, and Life Sciences (54171)

SIC

Services-Management Consulting Services (8742), Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

CMC Regulatory Affairs (Modules 2/3, Variations, Post-Approval CMC) (HLAGAKAB)

akta.pro secondary industry

Clinical Trial Informatics (EDC/CTMS/eCOA/eTMF) (HLAGAJAM)

Keywords

• Regulatory affairs consulting
• Clinical trial services
• Quality assurance consulting
• Pharmaceutical consulting
• Medical device compliance

Headquarters

HQ city

Wilrijk

HQ country

Belgium

HQ region

Europe

Offices10 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Technology or R&D, Marketing or Sales, Infrastructure

Revenue model

1. Professional Services: Consulting and advisory services in regulatory affairs, clinical trials, qualification and validation, quality assurance, software services, and market entry strategies for Pharma, Biotech, Medical Devices, and IVD industries. Revenue generated through project-based consulting engagements, audits, and specialized services.

Go-to-market motion1 record

Distribution channels2 records

Marketing channels7 records

Core offering

QbD Group is a life sciences consulting firm that delivers full-lifecycle support from idea to patient across Pharma, Biotech, Medical Devices, and IVD industries. The company sells professional services in Regulatory Affairs, Clinical Solutions, Qualification & Validation, Quality Assurance, Software Solutions & Services, Toxicology, Lab Services, Pharmacovigilance, Audits, and Companion Diagnostics, complemented by the Scilife SaaS quality management platform and the GMP-certified Quercus contract laboratory.

Product overview

QbD Group is a life sciences consulting firm offering a comprehensive ecosystem of services and subsidiary companies. The core offering includes consulting services across Regulatory Affairs, Clinical Solutions, Qualification & Validation, Quality Assurance, Software Solutions & Services, Toxicology, Lab Services, and Pharmacovigilance. The group operates several subsidiary companies: QbD IVD | Qarad (IVD regulatory affairs and QA, 35 years expertise), Quercus (GMP certified contract laboratory), Scilife (SaaS quality management platform), Simabs (monoclonal antibody CDMO), SciencePharma (Polish pharma consulting), and Rescop (computer system validation). Services span Pharma & Biotech, Medical Devices, In Vitro Diagnostics, Companion Diagnostics, and Combination Products industries, providing end-to-end support from idea to patient.

Differentiator

Problem solved

Functional benefit

Brands

• QbD IVD | Qarad: Specialized in Regulatory Affairs and Quality Assurance for In Vitro Diagnostic Devices, CE Marking, Quality Systems, and Electronic Instructions for Use
• Quercus
• Scilife
• Simabs
• SciencePharma
• Rescop
• PrecisionDx (CDx)

Products and services

• Regulatory Affairs Comprehensive regulatory affairs services covering EU market entry, CE marking, FDA clearance, technical documentation, and submission packages for MDR and global markets, serving pharma, biotech, and medical device companies.
• Clinical Solutions Full-service clinical trial support for medical device manufacturers and pharma companies, from strategy and protocol development to site selection, monitoring, and regulatory support.
• Qualification & Validation Scalable, flexible support from facility commissioning to equipment qualification, including commissioning, facility, utility, and equipment qualification, process validation, cleaning validation, analytical method validation, sterilization validation, and tech transfer.
• Quality Assurance Implementation of FDA, EMA, FAHMP, and ISO standards (ISO 13485, ISO 14971), internal and external audits by certified lead auditors, and lifecycle management for Medical Device Software and digital health solutions.
• Software Solutions & Services IEC 62304 software lifecycle compliance, design and development support, SaMD classification, AI Act readiness, cybersecurity assessments, and DevOps integration with QMS for medical device software makers.
• Toxicology Toxicology services supporting pharmaceutical and life sciences companies with regulatory compliance and safety assessment.
• Lab Services Laboratory services provided through the Quercus GMP-certified contract laboratory serving pharmaceutical and life science industries, including cosmetics, herbal products, food supplements, and medical devices.
• Pharmacovigilance Pharmacovigilance services including vigilance reporting, risk management, and post-market surveillance for pharmaceutical products.
• Audits Global GxP, MDR, and IVDR audits executed by certified experts, including GMP, GDP, GCP, GLP, GVP, ISO 13485, supplier/vendor audits, mock inspections, and internal audits for Pharma, Biotech, and MedTech clients.
• Medical Device CRO Full-service clinical trial support for medical device manufacturers, from strategy and protocol development through post-market clinical follow-up.
• IVD CRO Clinical performance studies, biostatistics, and regulatory support tailored for IVD manufacturers, with 24 years of experience and 280+ clinical performance studies across 45+ analytes.
• PrecisionDx (Companion Diagnostics) Companion diagnostics services synchronizing Pharma and IVD workstreams, covering the entire CDx lifecycle including regulatory affairs strategy, performance studies, legal representation, and test site monitoring.
• Scilife Software as a Service (SaaS) quality management platform for Pharma, Biotech, and Medical Devices to efficiently manage quality, process, and product related activities in compliance with GxP, MDR, and IVDR regulations.

Quantifiable outcome

• 1200+ clients supported including startups, scale-ups, mid-sized companies, and industry leaders
• +6 more outcomes

Named customers2 records

Segments6 records

Ideal customer profiles4 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature1 record

Partnerships

22 partnerships are on record, tiered core and minor.

• VigintakecoreStrategic or Co-development Partner · 13 May 2026Partnership to drive digital transformation of pharmacovigilance through intelligent automation and innovative digital solutions, combining regulatory expertise, quality systems, and advanced technology.
• RescopcoreOthers · 12 May 2026Acquired in May 2026 to expand Software Solutions & Services division and strengthen presence in Netherlands, Poland, Germany, Switzerland and US. Specialist in GxP compliance, computer system validation, and validation software for life sciences.
• delawarecoreStrategic or Co-development Partner · 27 November 2025Strengthened partnership to help life sciences companies accelerate digital transformation while ensuring full GxP compliance. Delaware is a global consultancy and SAP Platinum Partner.
• ASEBIOminorOthers · 12 November 2025QbD Group joins ASEBIO, strengthening commitment to quality, compliance, and safety within the Spanish life sciences sector.
• QaradcoreOthers · 6 September 2021Acquired by QbD Group in 2021 with intui's assistance. Specialized in Regulatory Affairs and Quality Assurance for In Vitro Diagnostic Devices. Now operating as QbD IVD | Qarad.
• QuercuscoreOthersGMP certified contract laboratory serving pharmaceutical companies and other life science and health industries, including cosmetics, herbal products, food supplements and medical devices.
• ScilifecoreOthersSaaS solution for Pharma, Biotech and Medical Devices to efficiently manage quality, process and product related activities according to compliance regulations.
• SimabscoreOthersContract development and manufacturing organisation for monoclonal antibodies, delivering fast, flexible and cost-effective solutions through continuous bioprocessing.
• SciencePharmacoreOthersPolish consulting and importing services leader for the pharmaceutical industry, with 120 specialists and over 820 prepared dossiers for medicinal products since 2004.
• PILS (Partners in Life Sciences)minorStrategic or Co-development PartnerPartnership between Flemish companies offering services and products in life sciences, improving the footprint of smaller companies towards big pharma.
• ISPEminorOthersInternational Society for Pharmaceutical Engineering - world's largest non-profit serving regulatory advancement throughout the entire pharmaceutical lifecycle.
• Flanders.biominorOthersNetworking organisation for life sciences sector in Flanders with 300+ members. QbD CEO Bart Van Acker is a board member.
• HollandBIOminorOthersFast-growing interest group representing Dutch biotech industry, uniting stakeholders from start-ups to large companies.
• Pharma.beminorOthersFederation of innovative biopharmaceutical industry in Belgium, representing over 130 companies and 35,000 employees.
• TOPRAminorOthersProfessional membership organization for individuals working in healthcare regulatory affairs, promoting excellence across the regulatory profession.
• RAPSminorOthersLargest global organization of professionals in regulatory and quality for healthcare products, home to the RAC credential recognizing regulatory excellence.
• HealixiaminorOthersBelgian community of all professionals active along the lifecycle of medicines, medical devices, IVD and other health-related products.
• BioWinminorOthersCompetitiveness cluster bringing together all innovation system players in health (biopharma and medtech) in Wallonia.
• BIVDAminorOthersNational industry association for manufacturers and distributors of IVD products in the UK, representing more than 95% of the industry.
• EMWAminorOthersEuropean Medical Writers Association - network of professionals representing, supporting, and training medical communicators.
• EAARminorOthersEuropean Association of Authorised Representatives, established in 2002 to represent organizations providing EU Authorised Representative services for medical devices.
• BeCROminorOthersProfessional association of Belgian Contract Research Organisations supporting clinical research and development of new pharmaceutical and medical device products.

Scale indicators15 records

Recent moves7 records

Expansion highlights6 records

Direct peers

• Pharmalex: Pharmalex is a specialist regulatory affairs and quality compliance consulting firm serving pharma and biotech. It is the closest direct peer to QbD Group in regulatory services breadth, geographic reach across Europe/Asia, and target customer profile.
• RQM+: RQM+ is a medical device and IVD regulatory, quality, and clinical consulting firm. It directly overlaps with QbD's IVD/MDR practice (Qarad) and competes for the same mid-market medical device manufacturers seeking CE marking and FDA clearance support.
• Qserve Group: Qserve is a European regulatory and quality consulting firm specializing in medical devices and IVDs. It competes head-to-head with QbD's IVD/MDR services and shares the same notified body and EU regulatory expertise positioning.
• ProPharma Group: ProPharma Group provides regulatory compliance, quality, and pharmacovigilance consulting for pharma, biotech, and medical device companies. Direct overlap with QbD's regulatory affairs, QA, and pharmacovigilance service lines.
• NSF International (Health Sciences): NSF's Health Sciences division offers regulatory consulting, training, and quality services for medical devices, pharma, and IVDs. Comparable in service scope to QbD's regulatory and quality consulting practice, with similar reliance on technical training and certification.
• Veranex: Veranex is a medtech-focused CRO and regulatory consulting firm offering clinical, regulatory, and quality services for medical device companies. Directly comparable to QbD's medical device CRO and regulatory practice.

Broad incumbents

• ICON plc: ICON is one of the world's largest clinical CROs with broad regulatory and consulting capabilities across pharma and medical devices. A larger, broader incumbent that competes with QbD's clinical solutions practice but at much greater scale and breadth.
• IQVIA: IQVIA is the largest life sciences services platform globally, combining clinical research, regulatory consulting, technology, and data analytics. A broad incumbent whose regulatory and quality consulting practice overlaps with QbD's mid-market services.

Emerging players

• MasterControl: MasterControl provides SaaS quality management and regulatory compliance software for life sciences. Direct competitor to QbD's Scilife SaaS platform in the eQMS market, with greater scale and a longer independent track record.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/qbdgroup
• Facebookfacebook.com/QbDGroup
• LinkedInlinkedin.com/company/qbd-group

Compliance4 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles13 records

Subsidiaries6 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A7 records

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about QbD Group