GCP Regulatory Bioanalysis
GCP Clinical Sample Analysis
As a GLP and GCP certified laboratory, Alderley Analytical can meet the regulatory compliance requirements to quantify molecules in biological samples in support of your clinical studies
Assays used to support clinical studies will have been fully validated and the analysis will be conducted to meet the FDA/EMA regulatory guidelines and will also be performed in compliance with GCP. Incurred Sample Analysis (ISR) will also be performed where required. Sample analysis data will be captured onto our validated LIMS system and the performance of the assays will be monitored in every batch of sample analysis performed. The data will be used to determine the pharmacokinetics in support of your clinical studies.
When we validate an assay for you we will assess the stability of your molecule in the biological matrix at different conditions, if needed we will also develop a way of stabilising your samples so you are fully informed on how to store and transport your samples to maintain the sample integrity.