AI-powered Quality by Design platform

Innovate better and faster with

Use an agile version of QbD to speed up and derisk the development of your innovative drug or medical device

Start structuring your QbD See how it works
Platform scope

easyQbD is designed to democratize the adoption of Quality by Design (QbD, ICH Q8) best practices by integrating an agile methodology, high-level statistical studies, and direct collaboration with regulatory, CMC, and biostatistics experts.

cybernano
by cybernano
Trusted ecosystem

We collaborate with top innovation and public sector partners.

ANR
BPI France
Grand Est
Sayens
European Commission
Eit Health
Satt Nord
Incubateur VCLS
Why easyQBD ?

A clearer path from the first proof of concept to the Regulatory Submission Dossier for Clinical Trials

Structure workflow

Optimize your development strategy

Optimize your development strategy

Support teams along an agile, preclinical QbD pathway with structured steps, overseen by regulatory and biostatistics experts, and featuring well-defined decision points.

Focus on critical variables

Focus on critical variables

Focus on critical variables

Identify product and process parameters that drive quality, safety and efficacy

Generate usable outputs

Generate usable outputs

Generate usable outputs

Produce structured reports, technical documentations and regulatory dossiers to support internal and regulatory discussions

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How it works

From product profile to Regulatory dossiers

Target Profile

Capture product intent, constraints and quality expectations early.

Gap analysis

Systematic analysis of regulatory deficiencies and ranking of questions to be addressed by level of criticality

Agile QbD

Each critical question is addressed through a QbD sprint, during which we prepare the design of experiments and perform statistical analyses.

Preparation of dossiers

The results of the QbD sprints are integrated into report templates intended for regulatory agencies for scientific advice requests or clinical trial submissions.

What is Quality by Design?

A proactive, data-driven development approach

Scientific approach

According to ICH Q8(R2), Quality by Design is a scientific and proactive approach applied to early-stage steps of development.

Data & risk-driven

Risk-based and data-driven methods are used to identify critical parameters, compute design spaces and validate established conditions.

Regulatory alignment

FDA and EMA support QbD to strengthen development robustness and improve documentation quality (ICH M4(R2)).

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Used in real projects

Projects using easyQBD

easyQBD has already supported structured work across real innovation programmes in biomedicine, mRNA therapeutics and medical devices.

DREAM (2024-2028)

Innovative Development of Medical Repair and Assistive Devices.

ACCESS (2021–2025)

Advanced Cell Control by Spectroscopic Sensors, biomedicines: improving yields and controlling production costs, 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.

Get started

Optimize your development time and costs with easyQBD.

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