Custom Synthesis of Drugs
From milligrams to multi-kilogram campaigns, we design and execute non-GMP and cGMP custom synthesis routes for:
- New chemical entities (NCEs) and pre-clinical candidates
- Reference standards and labeled internal standards (stable isotopes, 13C, 2H)
- Impurities, metabolites and degradants for method development
- Building blocks, advanced intermediates and final APIs under ICH Q7 controls
Our chemists leverage flow chemistry, cryogenic reactions, high-pressure hydrogenation, chiral resolution and preparative chiral HPLC to shorten timelines and reduce COGS. Full analytical packages (1H/13C NMR, HRMS, IR, elemental analysis, residual solvents, heavy metals) are provided with each shipment.