As innovative biotech company, you benefit from Exputec’s consulting experience in applying the right statistical tools for process development, process validation and quality controls. You significantly streamline your interactions with regulatory authorities such as FDA and EMA by adopting statistical best practices.

Process Development
You are looking for…
- Experimental designs for process development & characterization studies
- Exhaustive statistical analysis of your process develoment & characterization studies
- Integrated Process Modelling
- Scale-down model qualification
- Risk assessment facilitation, evaluation, or linkages to development data

Quality
You are looking for…
- Continuous process verification (CPV)in a GMP environment
- Statistical control of quality metrics
- Confirmation of equivalence for change control
- Analytical method development of Bioassay

Validation
You are looking for…
- Process Characterization
- Design of Experiment: planning or analysis
- Risk assessment: holistic and data based
- Scale-down model qualification
- Criticality assessment: CPP / CQA identification
- Establishing limits: NOR, PAR
- Justification of PPQ Runs
- Integrated process modelling

Process Engineering MS&T
You are looking for…
- Yield-improvement study plans
- GMP Data mining and analysis
- Integrated Process Modelling?
- Problem solving using statistical data mining and structured methodology

Operations
You are looking for…
- Soft Sensors: Optimization and development
- Real-time uni/multi variate parameter analysis during production
- Development and analysis of PAT technologies
Talk to one of our data scientists
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