Phone: +385 1 8886300

Email: fidelta@glpg.com

  • 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.

 

High-throughput bioanalysis

  • supported through DiscoveryQuant, a state of the art plugin that enables batch based compound optimization and rapid method and batch creation, including results review and reporting

Non-GLP quantitative & qualitative analysis

  • PK, PD and Toxicology studies
  • Metabolite Identification and profiling
  • Reactive metabolite screening

GLP bioanalysis

In support of preclinical development including:
  • Method development
  • Method validation
  • Method transfer
  • Cross validation
  • Sample analysis

Biomarker Analysis

  • State-of-the art technologies
  • Rapid sample turnaround
  • High quality data
  • Dedicated bioanalytical team
 
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