What Quality Assistance does

Quality Assistance S.A. is a privately held European Contract Research Organisation (CRO) founded in 1982 in Belgium, specializing exclusively in analytical sciences for innovative drug development. The company operates from a single 12,000 m² GxP-certified (GMP, GLP, GCP/GCLP) facility in Donstiennes (Thuin), Belgium, with a representative office in Köln, Germany, and serves pharmaceutical and biotechnology clients across all development phases from early research through marketing authorization.

The service portfolio is organized around five therapeutic modality areas (biotherapeutics, new chemical entities, cell and gene therapies/ATMPs, vaccines, and nanomedicines) and three core analytical service lines (CMC services, bioanalytical services, and statistical services). Technical depth is supported by advanced platforms including SPR (Biacore), bio-layer interferometry (Octet), automated immunoassay (Gyrolab xPlore), NGS (Illumina MiniSeq), and automated sample preparation (Andrew+ pipetting robot), all operating within an integrated single-site quality system. A proprietary LIMS/ERP, QALIMS, developed in-house over 20+ years, manages analytical data and integrates with electronic MES/LabVantage systems. The company is majority-owned by the Draux family, with BNP Paribas Fortis Private Equity as a minority investor since 2017.

Revenue is generated through project-based CRO contracts (professional services model) priced per engagement, with multi-year program relationships common, and no public pricing or revenue disclosure. The go-to-market is direct enterprise field sales supported by named account managers and business developers, reinforced by scientific content marketing, conference participation, a Scientific Advisory Board, and industry event leadership. Quality Assistance claims a 100% FDA/EMA first-submission approval rate across more than 2,000 contributions to innovative drug projects, and earned the 'Factory of the Future' label in 2026 as the first analytical CRO to do so.

Name

Quality Assistance

Legal name

Quality Assistance S.A.

Website

https://quality-assistance.com

Company type

Private

Founded year

1982

Operating status

Operating

Headcount range

101–250 employees

Short description

Quality Assistance is a privately held Belgian CRO providing GxP-compliant analytical sciences services (CMC, bioanalytical, statistical) for biotherapeutics, ATMPs, vaccines, and NCEs, operating from a single 12,000 m² integrated facility and serving global pharmaceutical and biotechnology clients across all development phases.

Ownership category

akta.pro rank

Product category

Contract Research Organization (CRO) / Analytical Sciences Services

NAICS

Testing Laboratories and Services (54138), Scientific Research and Development Services (5417), Research and Development in Biotechnology (except Nanobiotechnology) (541714)

SIC

Services-Commercial Physical & Biological Research (8731), Services-Testing Laboratories (8734)

akta.pro primary industry

Central Laboratory & Clinical Trial Testing CROs (HLAGAAAE)

akta.pro secondary industries

Bioanalytical & Biomarker CROs (PK/PD/Immunogenicity) (HLAGAAAD), Clinical Data Management, Biostatistics & Statistical Programming CROs (HLAGAAAF)

Keywords

• Contract research services
• Analytical method development
• Pharmaceutical bioanalysis
• Biopharmaceutical characterization
• GMP analytical testing

Headquarters

HQ city

Donstiennes

HQ country

Belgium

HQ region

Europe

Offices2 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Contract Research Services (CRO): Quality Assistance operates as a Contract Research Organisation providing analytical services to pharmaceutical and biotech companies. Revenue is generated through project-based contracts for analytical development, method validation, batch release testing, stability studies, bioanalytical services, and statistical services. Services span from early phase development through marketing authorisation. The company provides tailored analytical solutions aligned with regulatory expectations (EMA/FDA).

Pricing tiers

Go-to-market motion1 record

Distribution channels2 records

Marketing channels6 records

Core offering

Quality Assistance is a European Contract Research Organisation (CRO) providing analytical sciences services for innovative drug development. The company operates a single-site, GxP-certified (GMP, GLP, GCP/GCLP) integrated facility in Donstiennes, Belgium, delivering CMC analytical services, bioanalytical services, and statistical services across therapeutic modalities including biotherapeutics, NCEs, ATMPs, vaccines, and nanomedicines from early phase through marketing authorisation.

Product overview

Quality Assistance is a European Contract Research Organization (CRO) providing comprehensive analytical sciences services for innovative drug development. The company operates as a single-site facility in Belgium offering an integrated portfolio of analytical services organized around five therapeutic modality areas (Biotherapeutics, New Chemical Entities, Cell & Gene Therapies/ATMPs, Vaccines, and Nanomedicines) and three core analytical service lines (CMC Services, Bioanalytical Services, and Statistical Services). Services are delivered across all development phases from early research through marketing authorization, supported by advanced technological platforms including LC-MS, SPR, BLI, and automated sample preparation systems. All operations are conducted under GxP compliance (GMP, GLP, GCP/GCLP) with EMA and FDA regulatory expertise.

Differentiator

Problem solved

Functional benefit

Products and services

• CMC Services
• Bioanalytical Services GLP-certified bioanalysis including PK/TK studies, biomarker analysis, and immunogenicity assessment, supporting preclinical and clinical development phases for pharmaceutical and biotech clients.
• Statistical Services Statistical analysis services supporting analytical data evaluation, regulatory submissions, and quality control across all development phases for pharmaceutical and biotech clients.
• Biotherapeutics Analytical Services Comprehensive analytical support for biotherapeutics including monoclonal antibodies, antibody-drug conjugates (ADCs), proteins, and recombinant peptides. Services include analytical development, batch release testing, stability studies, and characterisation for biotherapeutic developers.
• New Chemical Entities (NCEs) Analytical Services Analytical services for new chemical entities including oligonucleotides, synthetic peptides, and synthetic small molecules, supporting development from discovery through clinical phases for pharmaceutical and biotech clients.
• Cell and Gene Therapies / ATMPs Analytical Services Analytical support for advanced therapy medicinal products (ATMPs) including mRNA, viral vectors (AAV), and cell-based medicinal products, addressing complex characterisation and regulatory requirements for cell and gene therapy developers.
• Vaccines Analytical Services Full analytical support for vaccine development including mRNA vaccines, subunit and polysaccharide-conjugated vaccines, recombinant protein vaccines, synthetic peptide vaccines, plasmid DNA vaccines, and recombinant viral vector vaccines, for vaccine developers and manufacturers.
• Nanomedicines Analytical Services Specialised analytical services for nanomedicine products, supporting quality assessment and characterisation of nanoparticle-based therapeutics for pharmaceutical developers.
• Phase-Specific Analytical Programs Tailored analytical support organised by development phase: Early Phase (custom method development in GLP/GMP environment), Preclinical Phase (GLP bioanalysis, PK/TK studies), Clinical Phase I/II/III (CMC and bioanalytical services), and Marketing Authorisation (method validation, batch testing, stability studies).

Quantifiable outcome

• 100% approval rate at first submission (FDA/EMA)
• +3 more outcomes

Named customers5 records

Segments3 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature6 records

Partnerships

Five partnerships are on record, tiered core and minor.

• Agoria and SirriscoreOthers · 10 February 2026Awarding bodies for the Factory of the Future label, which is based on a demanding maturity framework (minimum score of 4/5 in each area). The label recognizes companies as leading references in Industry 4.0 applied to their sector.
• Eyconis, Inc.coreStrategic or Co-development Partner · 1 October 2025Reinforcement of collaboration for clinical development of ophthalmic product EYC-0305. Letter of Intent signed during Belgian Economic Mission to US West Coast in presence of HRH Princess Astrid and California Governor Gavin Newsom. Quality Assistance provides GMP batch release testing, stability studies, and advanced analytical support based on more than 20 orthogonal analytical methods.
• ImmudexcoreTechnology or Integration · 27 June 2024Partnership for TCR Affinity Measurement Services. Quality Assistance uses Immudex's pMHC and TCR Monomers combined with SPR and BLI assays to determine affinity and kinetics of TCR:pMHC interactions. Enables pharmaceutical companies to outsource measurement of TCR affinity to a reliable service partner using high quality reagents. Immudex manufactures soluble TCR Monomers and TCR Dextramer® reagents with over 10 years experience in pMHC monomers.
• ECPM (École Chimie Polymères Matériaux)minorOthersDonated 2 automatic titrators and 567 LC columns to the school for educational and research purposes as part of WeCareWeAct sustainability program.
• HEPH - CondorcetminorOthersDonated 1 incubator to the institution for educational purposes as part of WeCareWeAct sustainability program.

Scale indicators8 records

Recent moves9 records

Expansion highlights6 records

Broad incumbents

• Charles River Laboratories: Global preclinical and analytical CRO with extensive bioanalytical, CMC and biologics characterization services. Comparable because it competes for the same pharma/biotech analytical contracts at significantly larger scale and with broader geographic footprint.
• Eurofins Scientific: Large European-headquartered testing services group with dedicated pharmaceutical analytical and bioanalytical labs. Overlaps with Quality Assistance on CMC testing, batch release and stability studies for pharma clients.
• WuXi AppTec: Global CRO/CDMO with significant analytical, bioanalytical and biologics characterization capabilities in EU and US. Comparable as a one-stop analytical and CMC partner serving pharma and biotech clients across modalities.
• SGS Health & Nutrition / SGS Life Sciences: Global testing, inspection and certification company with a dedicated Life Sciences/CRO division offering pharmaceutical analytical and bioanalytical services. Comparable in regulatory-grade CMC testing and method development.
• Pharmaron: China-rooted but globally operating CRO/CDMO offering bioanalytical, CMC and biologics characterization. Competes with Quality Assistance for analytical work from European and US pharma/biotech sponsors.
• Intertek Pharmaceutical Services: Total Quality Assurance provider with a dedicated pharmaceutical services business covering analytical development, stability and release testing. Directly comparable in regulated analytical CRO services.

Direct peers

• BioAgilytix Labs: Specialty bioanalytical CRO focused on PK/TK, immunogenicity and biomarker assays for biologics and gene therapy. Closely comparable to Quality Assistance's bioanalytical services for large-molecule and ATMP sponsors.
• NorthEast BioAnalytical Laboratories: US-based bioanalytical CRO providing LC-MS/MS and immunoassay services for small and large molecules. Direct competitor for outsourced regulated bioanalysis in pharma development programs.
• Celerion: Early-phase clinical and bioanalytical CRO specializing in PK/PD, immunogenicity and biomarker studies for small and large molecules. Comparable to Quality Assistance's GLP bioanalytical service line for first-in-human and clinical programs.
• AIT Bioscience (now part of company under Q² Solutions): Specialty bioanalytical CRO with regulated LC-MS/MS and immunoassay capabilities supporting pharma clinical development. Direct comparability in regulated PK/TK and immunogenicity assays for biologics and small molecules.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat6 records

Key risks6 records

Key highlights7 records

Customer concentration

• YouTubeyoutube.com/channel/UCArhfUlDSGMmpZGngz7-A3Q
• Facebookfacebook.com/QualityAssistanceBelgium
• LinkedInlinkedin.com/company/quality-assistance
• Instagraminstagram.com/qualityassistance
• Xx.com/QA_Belgium

Compliance6 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles6 records

Funding overview

Funding rounds2 records

Investors2 records

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

M&A

Investments

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

Frequently asked questions about Quality Assistance