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Tier 4 - Scientific Validation

Ensuring accuracy, compliance, and robust data for early development projects

Designed to support in vitro projects and early-stage non-regulated/non-clinical/clinical analyses, our Tier 4 – Scientific Validation offers method validation in addition to standard services.

  • Ideal for non-regulated, non-clinical, and clinical sample analyses during early development phases 
  • Method development, method validation, and sample analysis are managed as separate studies, providing clear structure and focus for each phase, allowing you to have full oversight of every stage
  • We provide you with a comprehensive and concise summary document containing analytical summary and comments, methodology, raw data, working solution scheme and representative chromatography

About our Tier 4 – Scientific Validation bioanalytical services

Our Tier 4 - Scientific Validation is suitable for support of in vitro projects, early development, non-regulated, non-clinical and clinical sample analyses where method validation assessments are required in addition to the offerings included in Tier 3. Studies are managed as separate method development, method validation and sample analysis studies, with the option of Quality Audit (QA) for method validations and sample analyses if selected. Method development studies include pre-validation assessments to ensure methods are suitable to progress to validation. The validation assessments will be based on industry guidelines, with flexibility as to which assessments are included. Typically, stability in matrix will be conducted up to a 1-month timepoint.

What does Tier 4 – Scientific Validation consist of:

  • Compound optimization (MS and LC)
  • Method development
  • Precision and accuracy assessment
  • Sample extraction
  • Inclusion of internal standard (generic/analogue/stable label)
  • Data processing
    • Concentration data
    • PK parameter interpretation available on request
  • Reporting

Find out more about our the other tiers

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