Quality Assistance Analytical expertise for tomorrow’s innovative medicines

© Quality Assistance © Quality Assistance

As a Contract Research Organisation (CRO), Quality Assistance provides its regulatory, scientific and technological expertise to large companies and SMEs in the pharmaceutical industry with a view towards developing and marketing innovative human medicinal products, in compliance with European and US regulations. Usually taking ten years or more from preclinical trials to marketing authorisation, this marathon effort involves the evaluation and assurance of the quality, safety and efficacy of these drug candidates. Quality Assistance distinguishes itself by providing customised solutions, including the definition of analytical protocols and specific analysis methods, as well as the mobilisation of a wide array of cutting-edge equipment for the acquisition and interpretation of the necessary data for the registration dossier submitted to the competent authorities. solely on the determination of the protein sulphur composition without having to use any reference substance. Quality Assistance’s approach was recognised by essenscia as one of the Top 10 innovations of 2019. And that's not all: from a product point of view, the company is actively working on the development of new techniques in connection with antibodies, cell therapy products, nanomedicine products and oligonucleotides. From a technological point of view, Quality Assistance is currently investing itself in mass spectrometry, flow cytometry and bioassays. From a regulatory point of view, the new pharmaceutical quality management concepts ICH Q8, Q9 and Q10 have been keeping them particularly busy. Founded in 1982, Quality Assistance achieved a turnover of €18.9M in 2018, 84% coming from exports. With 189 staff members and 77 customers, the company has achieved 10% average annual growth over the past 5 years while reinvesting between 10 and 15% of its turnover each year in the development of its analytical expertise and operational equipment.

Quality Assistance also sets itself apart by centralising all its expertise on a single site, thus making project management and communication more efficient. With more than 35 years of experience, proven reliability and stability in the scientific, organisational and financial domain, the company is a true European benchmark for large companies and biotechs. It is positioned in the market to provide the added value of innovative treatments and supports the development of the following treatments: immunotherapy, conjugated antibodies, new chemical entities, oligonucleotides, nanomedicine products, therapeutic vaccines, cell and gene therapies. The company clearly aims to have a true impact on the future of public health.

Always striving to provide full and reliable analytical support, Quality Assistance deploys its R&D activities for its customers (on a contract basis) along with its own internal R&D in order to update and acquire new analytical skills. This occurs in the form of a regulatory, scientific and technological surveillance of targeted products so as to diversify its analytical services. The company is proud to have developed the innovative ICP-MS approach for the absolute quantification of proteins, based With this strong and continuous improvement process in place, Quality Assistance has begun a fourth phase of major investments in its infrastructures. With the acquisition of 6 ha adjacent to its operations site, from 2020 it plans to lay the foundations for a new building that will make it possible to double the current office space and place an emphasis on human resources (with a target of 300 employees by 2030) and laboratories. An outstanding way to pursue its own growth and at the same time support the growth of its customers.

Quality Assistance Technoparc de Thudinie, 2 - B-6536 Donstiennes - Belgium Tel.: +32 (0)71 53 47 81 https://www.quality-assistance.com/