Stage 1 Process Characterization Consulting

Parameter Classification & Risk Assessments

We perform structured risk assessments to classify process parameters (PPs), identify potential CPPs, and prioritize variables for experimental evaluation.

• Risk ranking and filtering (RRF) matrices

• FMEA or Ishikawa-based root cause pathways

• Linkage to product CQAs and control strategies

Small-Scale Model Development & Qualification

We develop and qualify scale-down models that are predictive of commercial performance, ensuring data integrity and process relevance.

• Qualification protocols and acceptance criteria

• Model similarity justification for key parameters

• Control of scale-dependent variables (mixing, oxygen, shear)

Design of Experiments (DoE) & Process Characterization Protocols

We design and execute robust DoE studies to evaluate parameter impact, optimize ranges, and confirm design space.

Data Analysis & Summary Reporting

We provide comprehensive data analysis with clearly documented conclusions to support regulatory filings and design space justification.

• Graphical and statistical data interpretation

• Identification of proven acceptable ranges (PARs)

• Stage 1 Summary Reports aligned with FDA/EMA expectations

Process Control Strategy Development

We synthesize characterization outcomes into a risk-based, lifecycle-ready control strategy.

• Real-time parameter monitoring strategy

• CPP-based control logic and alarm limits