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