CRO Services

Bioanalytical Services (including GLP)

  • Discovery, non-clinical and clinical bioanalytical support
  • Large and small molecule capability
  • Biomarker assays
  • High capacity, fast turnaround sample analysis (Phase 1 support)
  • FIM and Phase I support
  • Automated sample analysis
  • All systems Part 11 compliant
  • PK kit manufacturing

Non-clinical/GLP Toxicology Services

  • IND enabling studies
  • Non-clinical animal studies
  • Pathology service
  • Rodents, rabbits, dogs, swine, monkeys and others
  • All dose routes except inhalation
  • In-house dose preparation and analytical support

Discovery Research Services

  • Research/Discovery experiments: efficacy, target validation, new compound screening
  • PK/TK, optionally utilizing BASi™s proprietary BASi Culex ® system
  • Automated simultaneous dosing and sampling from conscious freely-moving animals (rodents, dogs, and monkeys)
  • Real time data from stress free animals reduces the number of animals used
  • Samples: blood, bile, urine and feces
  • Automates in-vivo microdialysis sampling from blood and tissues
  • Lead optimization allows real time in-vivo ADME experiments

GMP-Compliant Pharmaceutical Analysis Services

  • Analytical Methods Services:
    • Method development, validation, revalidation, transfer
    • Ultraviolet (UV), Ion Chromatography (IC), Electrochemical (EC), Charged Aerosol (CAD), Msas Spectroscopy (MS), and Flurorescence (FD) detection capabilities
    • USP, ICH, EMA and FDA bioanalytical method validation compliance capabilities
  • Dosing Formulation Testing Services:
    • Matrix ranging from solvents to medical devices residue
    • GLP compliant testing
    • Dosing formulation stability testing
  • In Vitro Bioequivalence Analysis
    • Solid and semisolid formulations testing including tablets, powders, creams, ovules, and suppositories
    • 21CFR320 compliant testing
    • Testing compliant with FDA In-vitro guidance documents and method validation requirements