Services: Enhance your Value

Organic Synthesis

  • Custom Synthesis (> 95% purity, milligrams to kilograms scale)
  • Reference compounds
  • Building blocks & scaffolds
  • Key and advanced intermediates
  • Stable isotope labeled compounds

Process Research and Development

  • Synthetic pathway design, evaluation and scouting
  • New synthetic route development for target molecules
  • Optimization of difficult reaction step for existing route
  • Scale up

Medicinal Chemistry

  • Hit to lead
  • Lead optimization and SAR development
  • Analog synthesis
  • Focus library via parallel synthesis

Chemistry, Manufacturing and Control (CMC)

  • cGMP manufacturing of active pharmaceutical ingredients
  • Reference standard certification
  • Impurity and metabolite identification and characterization
  • Stability study
  • Analytical method development and validation
  • Regulatory document preparation and submission
  • Strategic planning of CMC for IND and NDA

Preclinical, Clinical and Regulatory Management

  • Assessment of ADMET properties for lead optimization and drug candidate selection
  • Design and management of IND-directed preclinical (in vitro and in vivo) studies
  • Regulatory planning, design and management of Phase I clinical trials
  • Regulatory document preparation and submission
  • Management of regulatory communications with the FDA and other agencies