IriSys provides pharmaceutical product development contract services specializing in formulation development, of clinical trial materials, and consulting related to the drug development process. IriSys custom approach to drug development is supported by the Companys scientific and regulatory experience in moving over 100 drug products from discovery to Phase I, Phase II, Phase III and, to commercialization. IriSys provides contract services related to the development of small and large molecules with a focus on formulation and cGMP manufacturing of clinical trial materials for Phase I and Phase II studies. The Company is differentiated from other contract organizations by the more than 125 years of pharmaceutical product development experience of its senior scientists in moving products from discovery to commercialization. IriSys scientists have contributed to the academic environments of University of Michigan, University of Texas at Austin, State University of New York at Buffalo and University of California, San Diego and, to the growth of companies like Warner Lambert/ Parke Davis, Tanabe Seiyaku, Avanir Pharmaceuticals, Schering Plough, Key Pharmaceuticals, and Dow Chemical Company. IriSys initiates each drug development process with major consideration for implementing the most effective regulatory strategy to achieve near and long term goals. The Company believes potential issues addressed early will accelerate overall development time. IriSys concentrates on generating data to support the rational development of a dosage form that will most accurately demonstrate a compounds therapeutic capabilities. A dosage form development program generally includes preclinical preformulation studies, excipient compatibility studies, analytical methods development and validation, pharmaceutical formulation development and optimization, stability studies, preparation of the Chemistry, Manufacturing and Controls (CMC) section of the Investigational New Drug (IND) application, manufacturing process development, cGMP manufacturing of clinical trial materials, and formal stability studies according to ICH Guidelines. IriSys maintains a cGMP facility.