Method development, validation, verification and transfer

We have extensive experience in development, validation, transfer and verification across a wide range of analytical methods. Our final protocols meet the most demanding regulatory requirements.

METHOD DEVELOPMENT/VALIDATION/VERIFICATION/TRANSFER

  • According to the to the ICH Guidelines, in accordance with pharmacopoeia
  • Consultationand parameter proposal for method validation
  • Protocols of validation/method verification
  • Report of validation/method verification
  • Flexible method transfer according to customer requirements
  • Protocols on method transfers
  • Reports on methods transfers

další služby

  • Technical contract drafts
  • Non-disclosure agreement drafts
  • Customer-specific solutions – method development
  • Single and multi-stage dissolution profiles