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.
