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Tier 5 - Full Validation

Ensuring compliance and integrity for critical GLP and GCP projects

Our Tier 5 – Full Validation supports non-clinical GLP and clinical GCP projects, conducting validations per industry guidelines.

  • Providing a tailored approach for non-clinical GLP and clinical GCP projects that need rigorous validation and compliance with GLP (Good Laboratory Practice) and GCP (Good Clinical Practice) standards
  • 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 5 - Full Validation bioanalytical services

The Tier 5 - Full Validation is designed to support non-clinical GLP and clinical GCP projects, with validations being conducted according to industry guidelines. Studies are managed as separate method development, method validation and sample analysis studies, with Quality Audit of the method validation and sample analysis studies. The method development study will include pre-validation assessments to ensure the method is suitable to progress to validation, and stable label internal standards used to ensure method robustness. Long term stability in matrix will be assessed to cover the sample storage period. Incurred sample reanalysis (ISR) can be included where required e.g. for pivotal clinical trials.

What does Tier 5 – 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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