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The first SaaS platform dedicated to Quality by Design (ICH Q8) to boost
the development of new drugs, medical devices, and analytical methods.
According to ICH Q8(R2), Quality by Design (QbD) is a proactive & scientific approach of drug development in which data-driven risk assessment methods are involved since the early design steps to optimize probabilities to meet efficacy, safety and quality specifications.
FDA and EMA strongly recommend the use of QbD to fill part of the Common Technical Document, an internationally agreed format for the preparation of applications regarding new drugs intended to be submitted to regional regulatory authorities.
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The main goal of QbD is to minimize the development timeline and costs while maximizing quality of the innovative product. Nevertheless, its implementation is not plug-and-play if you lack the required expertise and appropriate tools. easyQBD is the first digital platform developed to address this issue. The objective is to allow small and medium-sized companies to access this service and accelerate development.
easyQbD is a secured web-based platform that automatically guides non-experts through a QbD preclinical roadmap, which describes the key technical questions to be addressed to surely achieve TRL 3, 4 and 5. In each QbD study, you are accompanied by a QbD expert and a biostatistics engineer to design your experiments and analyze your data. Four reports are systematically produced to define the Quality Target Product Profile, the critical variables in formulation and manufacturing steps, their cause and effect relationships and predicted risks (design space).
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ACCESS (2021-2024) Advanced Cell Control by Spectroscopic Sensors, Biomédicament : améliorer les rendements et maîtriser les coûts de production, Grand Défi Biomédicaments
EXPERT (2019-2024) EXpanding Platforms for Efficacious mRNA Therapeutics, European Union’s Horizon 2020 programme, project no. 825828
TBMED (2019-2023) A testing bed for the development of high-risk medical devices, European Union’s Horizon 2020 programme, project no. 814439
