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

Over more than a decade since its founding, DSI has built a unique record of success, assisting global sponsors address product development, regulatory compliance, and project management challenges. Over the last decade, we have partnered with more than 200 unique sponsors not only here in the US but globally, having contributed efforts to more than 100 investigational applications, 25 full and supported new Drug Application (NDAs/BLAs)) and delivered briefing book resources for face to face and more recently virtual collaborations with the EMA and the US FDA.

This foundation stems from our team of subject-matter experts (SMEs) with years of pragmatic drug development experience combined with relentless project management. It is this understanding that allows us to provide a real-world field-tested viewpoint on how best to direct your new product from pre-IND enabling work, into initial and pivotal clinical trials, all the way thru to regulatory approvals and post approval lifecycle maintenance.

We think open exchange of information and directness are the footing for a successful outcome. We don't believe in a one size fits all approach and we provide an authentic assessment, representative timelines, dependable technical advice, and truthful submissions based on current and forward-thinking regulatory strategies. We are your deeper department.

In April 2021 we were thrilled to announce that DSI has just become part of ProductLife Group.

French-headquartered ProductLife Group (PLG) is well-known in the Life Sciences market with a track record of successfully managing global outsourcing programs and insourcing services for its international client base. The company is on a mission to help transform human health outcomes by optimizing regulatory affairs, safety & vigilance, and quality compliance for life sciences organizations around the world.

The fit between our two organizations could not be more perfect. We will complement PLG's growing biotech services portfolio. US biotech sponsors recognize DSI as a leader in consulting for go-to-market strategies and RA pre-market consulting, while PLG has a strong reputation for its capacity to manage the end-to-end outsourcing of regulatory affairs and pharmacovigilance activities worldwide.

Our merger with PLG will harness our combined strengths, offering our clients on both sides of the Atlantic support with their developed drugs approvals and post-approvals compliance, plus advisory services on the best market strategies to deliver a rapid ROI on their development. Together we will offer our clients increased pharmacovigilance capabilities - including a QPPV; pharmacovigilance consulting; and a fully validated safety database - as well as complementary toxicology-related services; RIM/electronic document management services; and support for medical device regulatory requirements.

We see enormous potential in this new chapter for DSI and for you, our clients. As a PLG company, we have the opportunity to become part of a global force in life sciences regulatory and compliance solutions and services, and we're incredibly excited to add our momentum to that effort.