Quality Assistance s.a. 2.78

European leader in analytical sciences

Quality Assistance S.A. is a leading European Contract Research Organisation providing the pharmaceutical industry with all the analytical services required by EMA and FDA regulations for the development and marketing of innovative human medicinal products.

We assist our clients from candidate selection, through non-clinical and clinical studies, to marketing authorisation, using our state-of-the-art, product-dedicated expertise in analytical sciences.
For each customer and each project, we design customised solutions, define analytical protocols, develop and validate specific new analytical methods and perform characterisation, stability, pharmacokinetic, biomarker and immunogenicity studies as well as batch release testing, in order to evaluate the Quality, Safety and Efficacy of the given drugs.

Quality Assistance S.A. is an expert for the development of
- Advanced Therapy Medicinal Products (Cell-Based MPs and Gene Therapy MPs)
- Biologics (monoclonal antibodies, ADCs, recombinant proteins and peptides)
- Nanomedicine products
- New Chemical Entities (e.g. protein kinase inhibitors, synthetic peptides, cytotoxics)
- Vaccines (recombinant protein vaccines, synthetic peptide vaccines)

The company holds a unique position on the market with
- All its laboratories on one site
- Bioanalysis (PK/TK/Immuno)
- Bioassays
- Biochemistry
- Chromatography
- Elemental Impurities
- Mass Spectrometry
- Microbiology
- Molecular Biology
- Protein Characterisation
- 150 highly qualified professionals
- Over 30 years’ expertise at the forefront of analytical sciences

Our core competencies are
- QUALITY (CMC)
- Development and validation of analytical methods
Characterisation
- Stability studies
- Batch (release) testing
- SAFETY/EFFICACY (Bioanalysis)
- Development and validation of bioanalytical methods
- PK/TK studies
- Immunogenicity studies
- Biomarker studies

The Quality Assistance environment is GMP, GLP and GCLP/GCP compliant.

www.quality-assistance.com