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
- 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
- Preparation and/or revision of Chemistry, Manufacturing and Control (CMC) regulatory submission
Contact
Vadim J. Gurvich, Associate Director
Telephone: 612-624-4728
Fax: 612-626-6862
Email: [email protected]