Method Remediation & Conversion

For existing proprietary or generic drug products, the analytical methodology to support production and batch release testing should continually be assessed in terms of validation, efficacy and efficiency based on new or improved analytical technologies over the products’ life cycle. Most commonly, this involves method remediation or method conversion of HPLC to UPLC as well as HPLC to LCMS or LCMS/MS.

Our general approach to Method Remediation and Conversion is the following:

• Feasibility of existing analytical method based on complete validation and/or tech package
• Remediation strategy incorporating a gap analysis and formal study design/protocol
• Optimization and conversion of the method to ensure method validation completion and reporting
• Method Transfer back to customer or establishment of internal SOPs for routine testing