Quality Assistance
Quality Assistance is a leading European Contract Research Organisation specializing in analytical sciences for the pharmaceutical industry. With over 40 years of expertise, they offer comprehensive analytical services, including method development, qualification, validation, and transfer, to support the development and marketing of innovative human medicinal products. Their mission is to accelerate access to new medicines through advanced analytical solutions and a commitment to quality, regulatory compliance, and sustainability.
Industries
Nr. of Employees
medium (51-250)
Quality Assistance
Donstiennes, Hainaut, Belgium, Europe
Services
End-to-end development, qualification and validation of methods for characterisation, potency, impurity profiling and stability testing, including method transfer and analyst training.
Comprehensive physicochemical, biological and microbiological QC testing under cGMP for batch release, with Certificates of Analysis and regulatory-aligned OOS/OOT procedures.
Absolute quantification of proteins and oligonucleotides using isotope-dilution ICP-MS/MS with low sample consumption workflows; validated applications include monoclonal antibodies and antibody–drug conjugates.
Packages combining SEC-UV/MALS/MS, icIEF fractionation and LC-MS workflows for comprehensive identity, size and charge-variant assessment compatible with GMP testing.
Development and validation of potency, ADCC and immunogenicity assays including alternative pyrogen testing methods to support regulatory-aligned validation.
End-to-end development, qualification and validation of methods for characterisation, potency, impurity profiling and stability testing, including method transfer and analyst training.
Comprehensive physicochemical, biological and microbiological QC testing under cGMP for batch release, with Certificates of Analysis and regulatory-aligned OOS/OOT procedures.
Absolute quantification of proteins and oligonucleotides using isotope-dilution ICP-MS/MS with low sample consumption workflows; validated applications include monoclonal antibodies and antibody–drug conjugates.
Packages combining SEC-UV/MALS/MS, icIEF fractionation and LC-MS workflows for comprehensive identity, size and charge-variant assessment compatible with GMP testing.
Development and validation of potency, ADCC and immunogenicity assays including alternative pyrogen testing methods to support regulatory-aligned validation.
Expertise Areas
- Analytical method development and validation
- Mass spectrometry-based biotherapeutic characterisation
- Absolute quantification by isotope-dilution ICP-MS/MS
- Oligonucleotide and mRNA analytics
Key Technologies
- High-resolution mass spectrometry (HRMS)
- LC-MS / LC-MS/MS
- 2D-LC/MS (multidimensional chromatography)
- Isotope-dilution ICP-MS/MS (absolute quantification)
News & Updates
In March 2025, the EPC announced the adoption of the new general chapter 5.32 of the European Pharmacopoeia.
Accelerating community access to future medicines is our vision, highlighted by our fundraising effort.
An event organized by Quality Assistance in 2025.
European Pharmacopoeia's new general chapter 5.32 adoption.
Fundraising to accelerate access to future medicines.
In March 2025, the EPC announced the adoption of the new general chapter 5.32 of the European Pharmacopoeia.
Accelerating community access to future medicines is our vision, highlighted by our fundraising effort.
An event organized by Quality Assistance in 2025.
European Pharmacopoeia's new general chapter 5.32 adoption.
Fundraising to accelerate access to future medicines.