Method Development &Validation ::

Our highly experienced scientists can conduct the following LC/MS/MS bioanaltyical services for your drug development needs:

• Method feasibility assessment
• Method development
• GLP Method validation in accordance with FDA Guidelines 21 CRR part 58
• Method transfer and cross validation

LC/MS/MS method development and validation is conducted  in accordance with the United States Food & Drug Administration (FDA), Guidance for Industry Bioanalytical Method Validation (21 CFR part 58) and in accordance with Custom Biologics’™ Standard Operating Procedures.

Method development projects can range from 1 week to a few months while validation is typically completed in 2 weeks.

Please contact Custom Biologics™ for ways in which we may assist you with method development and validation requirements.