Method lifecycle management

• Reference standards: 
  • Reference stock management using GMP (LIMS).
  • Monitor quantity real-time.
  • Periodical requalification according reference standards management program.
• Data trending:
  • Trending of acquired stability data using statistical software.
  • Lifecycle management of analytical methods by continuous method performance monitoring.
  • Monitor analytical procedure variability using control charts and statistical software tools.

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