Before prescription drugs and biomedical devices get to market, they undergo years of pharmaceutical development thorugh research and testing in accordance with FDA standards. From microencapsulation to assessment of bioengineered materials and biomedical devices, our experienced scientists and engineers assist in drug and biologic discovery in our world-class, FDA-inspected cGMP facilities and under inspected ISO 13485 protocols. We support drug development from preclinical to clinical trials. Those services include computational drug design, synthetics, formulation and cGMP clinical supplies, chemical process and analytical development, and project management.
With extensive experience in microencapsulation, we can quickly develop solutions for formulation and drug delivery problems such as solubility, stability, controlled delivery, delayed release, taste and targeting. Our experienced team can develop processes to overcome common process hurdles including safety, scalability and specialized purifications.
PHARMACEUTICAL DEVELOPMENT COURSES
Small Molecule Drug Development – This one-day course on Oct. 8, 2018, will provide the concept, strategies and tools for understanding process chemistry, manufacturing and control (CMC) decisions to support Investigational New Drug (IND) submission.