Eurofins CDMO offers comprehensive analytical services and stability studies to support drug development from pre-clinical to late-phase stages and commercialization.

Our expertise

Analytical method development

  • Method development
  • In-process controls
  • Method optimisation
  • Suitability testing
  • Starting material, intermediate & API release
  • Impurity characterization
  • Impurity isolation
  • GTI control
  • PGI control
  • Non-Chromophoric Detection (CAD, ELS, MS, RI)
  • Specification development

Method qualification/ validation

  • Method establishment
  • Method transfer
  • Phase appropriate method qualification
  • Method verification
  • Full method validation


Standard Qualifications

  • Identification standards
  • Physical and structure characterization
  • Reference standards

 

Commercialisation support

  • DOE studies
  • CPP assessment/support
  • Fate of impurities
  • Regulatory gap assessment
  • CMC support

Stability

  • Short-term stability studies
  • ICH stability studies
  • Photo stability (ICH Q1B)
  • Forced degradation studies
  • Trending studies and reporting