Our process development group is composed of passionate, highly skilled, and ingenious Ph. D. chemists having significant experience in synthetic process development of drug candidates, intermediates, and fine chemicals. The group uses state-of-the-art chemistry methodologies and creative design of synthetic routes to develop processes suitable for kilo- to large-scale manufacturing. In compliance with the regulations and guiding principles, our CMC service can provide clients with integrated pharmaceutical services, including the development of API production as well as regulatory filings.

• Route selection, process optimization, and safety evaluation
• Determination of freedom to operate (FTO)
• Scale-up synthesis for 14/28 days tox studies
• Kilo- to large-scale production (non-GMP and cGMP)
• Synthesis of process impurities and reference standards
• Salt selection and solubility studies