Method transfer

• Transferring your methods to a GMP-compliant laboratory environment via:
  • comparative testing
  • co-validation
  • complete or partial method revalidation
  • transfer waiver
• Based on a profound risk assessment, an implementation strategy is selected to match the complexity and specifications of the product and the corresponding procedure.
• Providing a comprehensive and well-designed transfer protocol upon mutual agreement of the strategy to be followed.
• Finalizing the transfer with a full-written transfer report with scientific interpretation of the data obtained in regard to the acceptance criteria.
• Offering a full package upon transfer, from release to stability storage under full ICH conditions.

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