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