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. Your analytical partner providing:
Outsource your analytical needs on one site for more efficiency including:
- customised solutions in terms of analytical protocols and innovative technologies throughout non-clinical and clinical development.
- a full range of equipment in Chromatography, Mass Spectrometry, Biochemistry, Cell Biology, Pharmaceutical Technologies and Microbiology, to meet all the challenges of developing and validating methods.
- regulatory, scientific and technical excellence with a problem-solving approach
- compliance with all applicable EMA, FDA and ICH regulations
- GMP, GLP, GCLP/GCP environment
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- Analytical development
- Validation of analytical methods as per ICH guidelines
- Stability studies
- Batch testing
Technoparc de Thudinie, 2