GLP Regulatory Bioanalysis
As a GLP certified laboratory, Alderley Analytical can meet the regulatory compliance requirements for your pre-clinical studies.
Our assays can meet the needs of the appropriate regulatory guidelines (e.g., FDA / EMA) and our Quality Management System (QMS) allows us to fulfil the requirements of the governing regulatory bodies including MHRA and ICH.
GLP PRE-CLINICAL SAMPLE ANALYSIS
As a GLP certified laboratory, Alderley Analytical can meet the regulatory compliance requirements to quantify molecules in biological samples in support of your preclinical studies.
Assays used to support these studies will have been fully validated and the analysis will be conducted to meet the FDA/EMA regulatory guidelines. 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, Toxicokinetics or simple exposure values in support of your preclinical studies.