Structure your QbD workflow, reduce uncertainty, and generate decision-ready outputs for drugs, medical devices and analytical methods.
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Guide teams through a preclinical QbD roadmap with consistent steps, shared logic and clearer decision points.
Identify product, formulation and process variables that drive quality, variability and development risk.
Produce structured reports and technical documentation ready to support internal and regulatory discussions.
Capture product intent, constraints and quality expectations early.
Identify critical variables and structure cause–effect relationships.
Support experiments with expert guidance and robust interpretation.
Document product profile, risks, logic and decision-ready outputs.
According to ICH Q8(R2), Quality by Design is a scientific and proactive approach applied early in development.
Risk-based and data-driven methods are used to improve product and process understanding from the earliest stages.
FDA and EMA support QbD to strengthen development robustness and improve documentation quality.
easyQBD has already supported structured work across real innovation programmes in biomedicine, mRNA therapeutics and medical devices.
Advanced Cell Control by Spectroscopic Sensors, biomedicines: improving yields and controlling production costs, Grand Défi Biomédicaments.
Expanding Platforms for Efficacious mRNA Therapeutics, European Union’s Horizon 2020 programme, project no. 825828.
A testing bed for the development of high-risk medical devices, European Union’s Horizon 2020 programme, project no. 814439.
