quality-assistance 产品代理

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quality-assistance 产品代理

Quality Assistance是一家领先的欧洲合同研究组织,为制药行业提供EMA和FDA法规要求的所有分析服务,以开发和营销创新的人类医药产品。

该公司在市场上占有独特的地位,其所有实验室都位于同一地点,拥有220名高素质的专业人员,并在分析科学领域领先35年。

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New Biological Entities

New Chemical Entities

Nanomedicine Products

Vaccines

Advanced Therapy Medicinal Products

mRNA



Quality Assistance 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.

 

The company holds a unique place on the market with all of its laboratories on one site, 220 highly-qualified professionals and more than 35 years’ at the forefront of analytical sciences.

 

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.