Services

Recent projects include work in these areas:

Develop and build statistical strategy for process and analytical development, scale-up, validation and ongoing monitoring.

Areas of specialty include:

• Quality by Design
• Justification of specifications
• Stability study design & analysis
• Estimation of shelf life & internal release limits
• Control strategy development
• Biological assay statistical design including cell-based potency assays
• Reference standard qualification & bridging
• Process characterization
• Statistical Design of Experiments (DoE)
• Formulation (mixture) experiments design and analysis
• Robust process & product design
• Multivariate modeling of starting materials and process performance
• Analytical method development, qualification & validation
• Comparability protocol and criteria
• Process validation strategy
• Continued Process Verification (CPV)
• Deviation investigation & resolution
• Independent 3rd party review of data packages to support submissions