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, 250 highly-qualified professionals and more than 40 years’ expertise 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.
Speed up people’s access to new medicines
Quality Assistance provides the pharmaceutical industry with all the analytical services required by EMA and FDA regulations for the development and marketing of innovative human medicinal products.
History of Quality Assistance
Quality Assistance replicates its DNA and expands from 6,000 to 12,000 m²
Challenge 2015-2021: Quality Assistance achieves its 2015 goal of 500 innovative drugs.
200 team members
Reaching 200 highly qualified team members in August 2020
Food and Drug Administration (USA)
The FDA has successfully inspected Quality Assistance.
BNP Paribas Fortis Private Equity Management S.A. enters the capital and the Board of Directors of Quality Assistance S.A.
New expansion for Quality Assistance
Acquisition of 5 hectares of land opposite its current facilities for future operational capacity increase
Agência Nacional de Vigilância Sanitária (Brazil)
ANVISA successfully inspected Quality Assistance in 2012 to verify compliance with Good Practices in Bioavailability/Bioequivalence of Medicines, in accordance with Law N°9,782/99 and Resolution R.D.C./ANVISA N° 103, of 08 May 2003. Quality Assistance is registered with ANVISA as a contract Bioequivalence facility.
PDMA, GCLP, GCP
Pharmaceuticals and Medical Devices Agency (Japan)
In March 2009, Quality Assistance was successfully inspected by the PDMA and received GMP compliance certification from the Japanese authorities.
Good Clinical Laboratory Practice Compliance
Quality Assistance has adapted its quality system to meet the requirements of sponsors who need the analysis of their samples from clinical trials to be done in accordance with GCLP (Good Clinical Laboratory Practice).
Good Clinical Practice Compliance
Quality Assistance has adapted its quality system to meet the requirements of sponsors who need the analysis of their samples from clinical trials to be done in accordance with GCP (Good Clinical Practice).
Valois S.C.R.L. enters the capital and the Board of Directors of Quality Assistance S.A.
Good Laboratory Practice Compliance
Quality Assistance is authorized by the Belgian authorities (Scientific Institute of Public Health) to carry out toxicity studies, residue studies, analytical and clinical chemistry testing, and pharmacokinetic studies according to the requirements of Good Laboratory Practice (GLP) - Directive of the European Commission 2004/9/EEC.
Food and Drug Administration (USA)
The FDA has successfully inspected Quality Assistance. Accordingly, Quality Assistance has been accepted and registered with the FDA as a contract pharmaceutical testing facility (FDA-FEI number 3002367943).
Société Régionale d'Investissement de Wallonie (SRIW S.A.) enters the capital and the Board of Directors of Quality Assistance S.A.
Sambrinvest becomes a Board Observer
Sambrinvest becomes a Member of the Board of Directors
Quality Assistance S.P.R.L. becomes a limited company: Quality Assistance S.A.
PHARMANAL S.P.R.L. is renamed Quality Assistance S.P.R.L.
Move to Donstiennes, Belgium
Move to Charleroi, Belgium
Good Manufacturing Practice Compliance
In accordance with the Royal Decree of 22/09/1966*, Quality Assistance is certified by the Belgian Federal Agency for Medicines and Health Products to perform the analysis of medicinal products.
as PHARMANAL S.P.R.L.