Roxana Segura's Colleagues at QUALITY ASSISTANCE S.A.
Roxana Segura's Contact Details
Argentina
QUALITY ASSISTANCE S.A.
Roxana Segura's Company Details
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:- Biologics (monoclonal antibodies, ADCs, proteins)- New Chemical Entities, oligonucleotides, peptides- mRNA- Nanomedicine products- Vaccines- Cell-Based and Gene Therapy Medicinal ProductsThe company holds a unique position on the market with:All its laboratories on one site (Donstiennes, Belgium)- Bioanalysis (PK/TK/Immuno)- Bioassays- Biochemistry- Chromatography - Elemental Impurities- Mass Spectrometry- Microbiology- Molecular Biology- Protein Characterisation220 highly qualified professionals40 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) testingSAFETY/EFFICACY (Bioanalysis)- Development and validation of bioanalytical methods- PK/TK studies- Immunogenicity studies- Biomarker studiesThe Quality Assistance environment is GMP, GLP and GCLP/GCP compliant.Visit www.quality-assistance.com for more information