DSI History

Our Story

DSI is a full-service regulatory drug development consulting firm for pharmaceuticals, biologics and new drug and delivery platforms.

Founded in 2007 by Edward Narke and Anthony Durning, who previously served more than 25 years combined at small emerging biotech, DSI has become the go-to consulting partner for companies large and small seeking to bring innovative, safe and effective products to market within the U.S.

Over a decade since its founding, DSI has built an unprecedented record of achievement, assisting clients all over the globe to address product development, regulatory compliance, and program management challenges. In the past ten years, we have served more than 150 unique clients, both in the US and international; we have contributed to more than 60 original INDs, 25 NDAs/BLAs (full and supported); and produced materials for more than 50 interactions with the European and US health agencies.

The cornerstone of this success is found in our team of consultants and program management staff, comprising subject-matter experts with decades of practical industry experience. It is this experience that allows us to provide an unparalleled "real world" perspective on how best to navigate your new product from target selection through testing, IND enabling work, clinical trials, regulatory approvals, and ultimately arrive at market in the most efficient manner.

We believe open communication and transparency are the foundation of a successful outcome for your new product. We don't believe in cutting corners or one size fits all approaches; we believe we have an obligation to provide an honest assessment, realistic timelines, credible science, accurate submissions, and an effective regulatory strategy. We hold ourselves to the highest standards of professionalism, scientific practice and ethics. We take pride in delivering innovative solutions and extraordinary results for clients who partner with us.