IriSys provides contract pharmaceutical product development and manufacturing services specializing in formulation research and development, cGMP manufacturing of clinical trial materials and commercial pharmaceutical products, and consulting related to the drug development process.
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.