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Bioanalysis

Our services

  • PK/TK studies

    • Drugs
    • Metabolites
    • GLP supportives analysis in vehicles/buffers
  • Drug-Drug Interaction (DDI) studies

  • Immunogenicity Assessment

  • Biomarkers



  • (Bio)Analytical methods

    • Full development
    • Cross validation
    • Partial validation
    • EMA / FDA validation
Pharmacokinetics & Toxicokinetics / Biomarkers / Immunogenicity
Drug, Metabolite assays UPLC (MS/MS), ICP (MS)
Biomarkers ELISA, ECL (MSD), UPLC (MS/MS), Luminex
Vehicles / Buffers (U)HPLC (UV, MS), ICP (MS)
Immunogenicity ELISA, ECL (MSD), SPR (Biacore), Cell-based assays

Wide expertise

  • Strong experience in NCEs (30 years) and in Biologics (15 years)
  • All laboratories on one site
  • High throughput for sample analysis from FIM studies
  • Ability to handle cytotoxic compounds and radiolabelled samples
  • Extraction from Dried Blood Spot samples

All matrices

  • Whole blood, plasma, serum, urine
  • CSF, vitreous fluid
  • Brain homogenates
  • Tissues, tumors
  • Vehicles
  • Buffers

Analysis and reporting

  • Reporting in accordance with GLP/GCLP/GCP
  • Deviation SOPs compliant with EMA/FDA requirements
  • PK/TK reporting, expertise in WinNonlin

Communication

  • A dedicated team in close contact with you, dealing with your project efficiently and helping you to meet your objectives
  • Qualified Study Director / Principal Investigator / Analytical Project Manager
  • Experience in working on multi-site studies

Quality Assurance

  • GLP certified
  • GCLP/GCP compliant
  • Independent quality department to ensure compliance with Quality Standards


You can download the brochure
bioanalysis-quality-assistance

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