- State-of-the-art Analytical Services facility in the USA
- Physical and Chemical Characterisation
- Method Development and Validation
- API & Drug Product Testing
- Stability Testing
- Impurity Identification and Structure Elucidation Services
- Bioanalytical Services
Our GCLP bioanalytical laboratories use Agilent and Sciex LC-MS/MS technologies for the analysis of blood, plasma, serum and urine for human and animal clinical trails. A strategic alliance with a leading 40 bed clinical research organisation (Biokinetic Europe Ltd) enables us to deliver total solutions for your human clinical trial needs.
For clinical trials we can provide dose formulation analysis as well as the quantitative analysis of drugs and their metabolites in biological matrices. We can offer; full method development and validation for new analytical methods; off the shelf proprietary methods; method transfer validation; or tailoring of methods for specific requirements. We have invested heavily in LC‑MS/MS instrumentation and the use of 96 well plate technology help in our rapid turnaround of samples. Our timely, proactive and flexible approach ensures that results are available in the shortest possible timeframe and that data from dose-ranging and escalation studies can be available within 48 hours. Samples are tracked from clinic to final reporting and we can supply barcoded sample labelling kits if required. We offer -20 oC and -80oC storage which is monitored 24/7. We have standard report formats which can be customised to fulfil specific client requirements.