Strategic Pharmaceutical / Drug Development Consulting
IRISYS’ pharmaceutical consulting services include drug development guidance and regulatory strategies for all stages of the U.S. Food and Drug Administration (FDA) drug approval process, as well as special assistance for international clients. Through our pharma consultancy, 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 as a successful drug development and pharma consulting company 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. Our pharma consulting capabilities include designing and implementing 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 pharma consulting 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’ drug development consulting services 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.