Process characterization/control

• Process assessment during the complete product development journey ensuring process understanding and defining critical quality attributes using in-house or product specific methods.
• Controlling your critical quality attributes by analyzing as in process control (IPC) and/or final release testing ensuring quality and safety.

Meet our scientists

Our end-to-end analytical solutions for drug development

• Analytical Method and Lifecycle support

  • Assay & Method development
  • Method qualification
  • Method validation
  • Method transfer
  • Method lifecycle management
  • CMC consultancy
• Stability studies

  • ICH conditions
  • In-use stability
  • Forced degradation studies
  • Predictive stability studies
• Characterization studies

  • Developability
  • Product characterization
  • Process characterization/control
• Release testing

  • Non-GMP/GMP batches
  • Tox, PPQ and validation batches
  • Clinical and commercial batches