Our Services

We are committed to providing our clients with the highest quality service

Statistical Consulting

  • Design of experiments

  • Design and analysis for Process development, characterization and scale up

  • Design and analysis for analytical method - optimization, validation & qualification

  • Design and Analysis for Drug Substance and Drug Product Formulation

  • Method transfer

  • Bridging assays

  • Qualification of new and/or critical reagents/raw materials

  • Setting acceptance criteria and Operating Ranges

  • Design and Analysis for Drug Substance and Drug Product Formulation

  • Setting specification limits

  • Root cause analysis

  • Multivariate Analysis

  • Continued process verification

  • Annual Product reviews

  • Stability analysis

  • Shelf-life estimation

  • Statistical process control

  • Developing and implementing tools for data collection, automatic analysis, reporting, and visualization

  • Sampling plans

Training

  • Basic Statistics

  • Graphical analysis/Visualization

  • Regression & Correlation – univariate, multivariate analysis, logistic regression

  • Multivariate analysis – Principal Component Analysis, Partial Least Square, Tree Analysis

  • Design of Experiments –

    • Basic (full/fractional factorial, Placket Burman),

    • Advance (Response Surface, Mixture, combination of process and formulation)

  • Setting Specification

  • Understanding Sources of Variability

  • Shelf-life estimation

  • Stability Analysis

  • Statistical Process Control

  • Capability Analysis

  • Continued Process Verification

Solutions

  • Statistical Process Control/ Continued Process Verification

  • Annual Product Review

  • Automated data collection, analysis, visualization & report

  • Setting Specifications

  • Setting alert limits for trends/out of specification

Six Sigma

  • Six Sigma deployment for organizations (manufacturing or service)

  • Coaching

  • Project Management

  • Training:

    • Green Belt

    • Lean Six Sigma Black Belt

    • Six Sigma for Design

    • Tools for problem solving (Six Sigma toolbox)

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