Analytical Method Development
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Bioanalytical Assay Development
Tailored assay development that is scientifically appropriate for its intended use, scalable across development stages, and aligned with regulatory expectations.
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Method Transfer and Optimization
Method transfer includes demonstrating the specificity of matrix components, system suitability, and accuracy of the previously validated method.
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Fit-for-purpose Validation (Partial, Full, and Cross-Matrix)
Customized analytical methods using a risk-based approach to ensure reliable outcomes and provide essential data insights.
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cGMP-compliant Support
Each assay strategy aligns with cGMP-compliant expectations for the therapeutic modality, biology, and development stage, from preclinical through clinical studies.