IRISYS provides its clients drug development guidance and regulatory strategies at all stages of the U.S. Food and Drug Administration (FDA) drug approval process, including special assistance for international clients. We serve as your development partner from planning for your initial FDA meeting to the commercialization of your product.
IRISYS WILL BE YOUR PARTNER AND GUIDE YOUR COMPANY THROUGH THE FDA DRUG APPROVAL PROCESS.
Experience and expertise
IRISYS’ management has a deep understanding of current regulatory philosophy and standards. We have direct experience in working with the Food and Drug Administration (FDA) at all levels. Our history of successful drug development spans a wide range of therapeutic categories including anti-viral, neurology, oncology, gastroenterology, and OTC products.
The IRISYS advantage
IRISYS creates tailored plans for achieving product approvals as quickly and cost-effectively as possible. Decades of experience working with regulators gives us the insight to pursue non-traditional approaches. We design and implement science-based strategic plans that have saved our clients time and money.
What IRISYS can do for you
IRISYS specializes in helping U.S. and foreign companies through the entire FDA regulatory process. We personalize our services to the needs of each client as new products are moved from the lab to commercialization. IRISYS will work with or function as your Head of Regulatory. We serve as your development partner from planning for your initial FDA meeting to the commercialization of your product.
For foreign companies, IRISYS will support your special needs by meeting at your location, providing translations, bringing your products to the U.S., and educating your personnel about FDA regulatory requirements.