Custom Approach to Drug Development
IriSys provides contract pharmaceutical product development and manufacturing services specializing in formulation research and development, cGMP (current Good Manufacturing Practices) manufacturing of clinical trial materials and commercial pharmaceutical products, and consulting related to the drug development process.
IriSys’ strategic consulting services assist our clients through all stages of product development. Our drug development & regulatory services include the design and implementation of science-based strategic plans that have saved our clients time and money. We serve as your development partner from planning for your initial FDA meeting to the commercialization of your product.
IriSys’ scientific and regulatory experience includes having moved more than 100 drug products from discovery to Phase I, Phase II, Phase III and into commercialization. IriSys is differentiated from other contract organizations by the more than 125 combined years of pharmaceuticals product development experience of our senior scientists and leadership team.
IriSys aids foreign companies bringing drugs through the U.S. FDA approval process. We support the special needs of international clients by meeting at your location or hosting your representatives at our facility, providing translations, bringing your products to the U.S., and educating your personnel about FDA regulatory requirements.