As worldwide drug development partner to biotechnology/pharmaceutical companies, we move lead molecules from discovery through the IND and NDA development phases. We utilize a 20-year track record for excellence in API chemical development and scale-up, including production of pre-launch quantities of a marketed block-buster drug. Our one site has chemistry, biology, and regulatory support services, offering combined solutions that include discovery lead optimization, preclinical development (incl. in vitro/in vivo pharmacology/toxicology, drug metabolism evaluations), API CMC development (methods dev., QC testing, stability studies, polymorph and salt screening) and API process scale-up and production from preclinical through commercialization. 8 Kilo-labs (4 cGMP-compliant) with reaction systems to 50 L. 17 GLS/SS pilot-scale reaction systems, 40-3,000 L, with operating ranges of -55 to +165C and FV - 450 psig, total capacity of 17,000 L. Pilot-scale flash chromatography system. Research-grade analytical instrumentation, BA Center with 8 LC/MS-MS instruments. Complete GLP animal testing facilities. Environmental control/containment systems. US FDA, cGMP, GLP, EPA and OSHA compliant.