Available Resources

  • Preclinical pharmacology and efficacy studies
  • Identification and evaluation of intermediate biomarkers
  • Formulation optimization for enhanced bioavailability and clinical usefulness
  • Analytical method development for investigational agents in bulk form and in biological fluids and tissues
  • PK and PK-PD modeling to optimize dosing regimen
  • Scale-up non-cGMP and cGMP production of an investigational agent
  • Stability testing for bulk and formulated material
  • Preclinical Investigational New Drug (IND)-directed GLP toxicology studies
  • Regulatory support

View the Prime Contractors 2019-2023.