IriSys Information

IRISYS, LLC was founded in 1996 by Gerald J. Yakatan, Ph.D. with the goal of establishing a premier West Coast pharmaceutical product development contract services organization. IRISYS has grown from a small laboratory focused on formulation development to an organization that offers pharmaceutical research and development, cGMP manufacturing for clinical trials materials and commercial pharmaceutical products and full regulatory strategic planning services including pre-IND FDA meetings. IRISYS provides a full spectrum of pharmaceutical product development contract services designed to move compounds from early research to Phase I/II clinical trials. As a result of years of hands-on experience in every facet of pharmaceutical formulation, IRISYS understands what is required to move a compound through the development process. IRISYS often works with companies that need to bring compounds to First in Man studies when the bioavailability is unknown and where there is limited stability data. These companies need to generate data in humans as early as possible to determine if the compound of interest is a candidate for further development. IRISYS develops and manufactures pharmaceutical dosage forms under contract to various product sponsors/owners. IRISYS manufactures products for preclinical [animal] toxicology studies, and for all phases of human clinical trials [I, II, III]. IRISYS works in all therapeutic categories [e.g. Cancer, Chemotherapy, Cardiovascular, Endocrine/Metabolic Disorders, Central Nervous System, Dermatology, Gastrointestinal, etc.]. IRISYS manufactures a wide range of dosage forms, [e.g. oral tablets, oral capsules, oral liquids, sterile injectable products, liquid filled hard gelatin capsules, creams & ointments]. The work is regulated by the FDA and the clinical trial materials are always made under an IND.