We help you with the technical writting to support the CMC part with enhanced approaches (QbD) and advanced Control Strategies.

Quality by Design in chemical-pharmaceutical development

QTPP, CQAs, CPPs. Formulation and process design  protocols and reports.

Risk analysis during development, scale-up and process validation.

Consulting, training and advice on the practical application of Design of Experiments: screening, optimization and robustness.

Advice and project management on the selection and deployment of Process Analytical Tecnologies PAT .


Reverse QbD and process improvement in pharmaceutical operations. Six Sigma proyects.

We lead quality improvement and optimisation projects on legacy products.

Our Black Belt consultant makes a previous statement of quality goals and return of investment ROI.

We apply Six Sigma DMAIC methodology to identify root causes of low quality/performance, specially adapted to regulated industrial operations.

Final goal is restoring stability and process capability to reduce non-conformance rates to acceptable levels.