“Working with Catalyst over the last few years has really helped my team to develop a clear regulatory strategy for some of the more complex and unusual regulatory challenges. Nancy and her team have provided critical insight into FDA processes and practices. As I’m now working in an early stage technology based company, the advice and guidance from Catalyst can have an even greater impact.”

– Foundation Medicine, Michael Doherty, Senior Vice President, Product Development

“Proteus is developing cutting-edge products that combine sensor technology and drugs in an unprecedented way. Our products don’t fit neatly into traditional FDA review pathways. So Catalyst Healthcare Consulting worked strategically and collaboratively with FDA to help us forge new, innovative pathways tailored to our digital health products. Nancy and her team worked with FDA leaders and a broad array of policy decision makers to reach a shared understanding of our platform technology and the appropriate review standards for bringing particular products to market. In the process, Catalyst helped us deepen relationships with FDA decision makers and provided additional value on the reimbursement front.  Catalyst team members are great consultants and fun to work with too. And they are always watching out for our company’s best interests across a wide range of policy arenas. Catalyst is an indispensable partner in Proteus’s go-to-market strategy.”

– Proteus Digital Health, George Savage, MD, Co-founder and Chief Medical Officer

“The regulatory intelligence and strategic insight that we get from Catalyst HCC has been invaluable. From product-specific to broad policy efforts, Catalyst proactively identifies innovative ways to engage with policy makers and activities in order to support our mission of providing value to patients living with severe diseases. Though they were initially hired to focus on regulatory intel, Catalyst has expanded its role with us over the years due to their ability to reliably and accurately interpret and anticipate events. They have become an integral part of our team. Based on the intel from them, we’ve been able to work strategically to seize opportunities and avoid regulatory and policy pitfalls.”

– UCB, Inc., Deb Hogerman, Vice President, Global Regulatory Therapeutic Area Head, Immunology and Bone

“We’ve been growing our regulatory and scientific policy footprint for the last several years, but we can’t be everywhere all the time. Over the years, Catalyst Healthcare Consulting has allowed us to amplify our regulatory intelligence and regulatory policy capabilities, without having to grow the staff. Their high quality work has helped us raise the department’s profile internally and externally. The insightful strategic counsel, institutional knowledge and immediate customer service they provide is invaluable. It is not a coincidence that Nancy and her team have supported me and my departments over the last 10 years with three distinct pharmaceutical companies.”

– EMD Serono, A.B., Head, Global Regulatory and Scientific Policy