Chemical Process Development Services

submenu

molecule

Drug Synthesis 

  • Synthesis of lead molecules, drug candidates and advanced intermediates
  • Route selection, process development and optimization
  • Scale-up of pre-clinical and clinical drug candidates to kg quantities
  • Drug synthesis under cGMP conditions to support Phases I and II clinical trials
  • Raw materials sourcing
  • Synthesis of reference standards and metabolites
  • Process optimization and technology transfer
  • FDA-inspected API manufacturing facility

More Services

Drug Analysis

Drug Analysis

  • Analytical method development for identity, purity, potency of drug substances
  • Characterization, proof of structure, stereochemistry
  • Development of test specifications for drug substances
  • QC testing for cGMP processes: raw materials, release testing, in process testing, cleaning validation
  • Certificate of Analysis
  • IND-enabling stability studies

Regulatory Support

Regulatory Support

  • Preparation and/or revision of Chemistry, Manufacturing and Control (CMC) regulatory submission

Content

Vadim J. Gurvich, Associate Director
Telephone: 612-624-4728
Fax: 612-626-6862
Email: vadimg@umn.edu