Preclinical Services

With its GLP certified and FDA inspected bioanalytical laboratory network, SGS has an international reputation for assay of drugs in biological fluids as well as for complex method development and validation.

SGS aims to guide you through the selection process of lead candidates and support pre-clinical and clinical studies for regulatory submissions of investigative and new drug substances. These include:

• pre-trial consulting
• feasibility evaluation
• study design
• study set-up and project management

The following preclinical services are provided:

• Bioanalytics including method development and validation
• Animal metabolite profiling and balance study (14C-labelled drug)
• Toxicokinetic analyses and report writing
• In vitro cell-assay: reconstructed human epidermis, corneal epithelial tissue, CaCO2 cells
• Immune function testing:
  • immunogenicity, including neutralizing antibodies
  • flow cytometry
  • cytokine multiplexed ELISA
  • cytotoxicity, phagocytosis/opsonization