We provide bioanalytical services to support the development of small and large molecule therapeutics, generics and biomarkers in all stages of the drug development process, from discovery to post launch marketing (including bioavailability and bioequivalence studies).
We provide effective and timely communication ensuring a successful collaboration. We guarantee no surprises. Operating with minimal bureaucracy, we are able to be responsive to your requirements. Your satisfaction is a measure of our success.
Assay Development and Validation
- Our in-house method development experts can develop fit-for-purpose, highly sensitive and highly specific bioanalytical and biomarker assays in a diverse range of species and matrices, to support drug discovery and drug development projects.
- We can provide fit-for-purpose validated assays appropriate for any stage of the drug development process, ranging from little or no validation to a full validation to meet regulatory (GLP/GCP) requirements.
- Prior to any sample analysis, we liaise with our customers to ensure any sample stability issues have been considered, ensuring that the samples are collected, transported and stored correctly.
- Our data is of the highest quality, will meet the appropriate regulatory requirements and will be delivered on time in the format you require.
- Our experienced in-house and partner Kineticists use WinNonLin or similar software packages for non-compartmental data analysis to provide TK or PK interpretation for your non-clinical and clinical studies. For more details about our partner Kineticists, please visit our Partner Lab page by CLICKING HERE.
- We can tailor our reports to meet your needs. These can range from an Excel data summary for drug discovery or investigational studies, to a full report to meet regulatory requirements.
- We can use our in-house report formats or bespoke report formats.
- Our experts can advise on the most appropriate bioanalytical strategy and requirements throughout the drug development process.
- We can also review bioanalytical validation and study reports to ensure that the content is scientifically sound and meets regulatory requirements.
One of Alderley Analytical’s Partner labs is called BioPharmaSpec Ltd. They are an independent analytical research laboratory (CRO), specialising in Discovery, Early Phase and Pre-clinical characterisation and testing of Biopharmaceutical Products. For more details about Biopharmaspec please visit our Partner Lab page by CLICKING HERE.