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. After twenty years, the Company has grown from a small laboratory focused on formulation development to an organization that offers pharmaceutical formulations, cGMP manufacturing for clinical trial materials and commercial pharmaceutical products, and most recently, full regulatory strategic planning services.
We provide unparalleled attention to our clients, customized services, and direct access to senior-level experts.
IriSys serves as the R&D and manufacturing partner for innovative biopharma companies.
IriSys provides a broad spectrum of pharmaceutical product development contract services designed to move compounds from early research through the clinical trials required for regulatory approvals.
IriSys manufactures products for preclinical [animal] toxicology studies and for all phases of human clinical trials [I, II, III], as well as commercialized products. We work in all therapeutic categories [e.g. Cancer, Chemotherapy, Cardiovascular, Endocrine/Metabolic Disorders, Central Nervous System, Dermatology, Gastrointestinal]. We manufacture a wide range of dosage forms including oral tablets, oral capsules, oral liquids, sterile injectable products, liquid filled hard gelatin capsules, creams and ointments.
IriSys’ capabilities include both small scale batches and commercial product manufacturing. Our work is regulated by the FDA and the clinical trial materials are always made under an IND [Investigational New Drug application]. IriSys is routinely audited by the FDA to verify compliance.
IriSys often works with companies that need to bring compounds to First in Man studies when the bioavailability is unknown and the stability data is limited. We have saved our clients time and money by enabling them to generate human data as early as possible to determine if the compound of interest is a candidate for further development.
IriSys will guide your company through the U.S. FDA drug approval process.
IriSys specializes in helping U.S. and foreign companies through the entire Food and Drug Administration (FDA) regulatory process. We personalize our services to the needs of each client as new products are moved from the lab to commercialization. Our offerings include strategic regulatory plans, pre-IND meeting package preparation, and participation in FDA meetings.
When you work with IriSys, you benefit from decades of pharmaceutical research and development expertise.
IriSys’ scientific management is composed of prominent pharmaceutical product development leaders from industry and academia. As a result of years of hands-on experience in every facet of pharmaceutical research and development, the IriSys team offers the expertise of bringing new products to the market quickly and efficiently. Under the direction of Gerald J. Yakatan, Ph.D., IriSys has built a reputation for excellence and timeliness in pharmaceutical development services.