We are experts in CMC statistics offering holistic solutions

We have expertise in the practical implementation of a wide range of statistical methodologies in all parts of the pharmaceutical product lifecycle. We tailor statistical solutions to solve the true problem, incorporating  relevant context such as manufacturing or business processes, goals, logistics, and regulatory requirements. Some areas of our expertise:

  • Quality by Design
  • Lifecycle Process Validation: Strategy and Execution (Design, PPQ, and CPV)
  • Continuous Manufacturing
  • Analytical Similarity
  • Design of Experiments (DOE)
  • Sampling Plans
  • Acceptance Criteria/Specifications
  • Equivalence/Comparability
  • Bayesian Methodology
  • Root Cause Analysis
  • Training and Capability Building
  • Business processes