- Fidelta has extensive capability, expertise and experience in the field of bioanalysis providing contract bioanalytical services including non-GLP and GLP quantitative analysis in support of discovery and preclinical development activities, clinical study samples, as well as biomarker and qualitative analysis.
- Rapid turnaround quantitative analysis is ensured through efficient sample preparation, state-of-the art LC-MS/MS systems, experienced and trained scientists and a dedicated instrument maintenance team.
- Our independent quality management (QM) group ensures adherence to analytical methods, standard operating procedures (SOPs) and GLP regulatory obligations and guidelines. All studies are performed in-line with SOPs and guidelines, as well as EMA and FDA bioanalytical guidelines.
Non-GLP quantitative & qualitative analysis
- PK, PD and Toxicology studies
- Metabolite Identification and profiling
- Reactive metabolite screening
In support of preclinical development including:
- Method development
- Method validation
- Method transfer
- Cross validation
- Sample analysis
- State-of-the art technologies
- Rapid sample turnaround
- High quality data
- Dedicated bioanalytical team