Welcome to Catalyst Healthcare Consulting, Inc.
Catalyst Healthcare is a boutique regulatory affairs advisory firm.
We work closely with our clients to anticipate and shape complex health care issues that can affect their business, and to address the FDA regulatory hurdles that can arise during the product development and approval process. We create engagement strategies to find win-win solutions that benefit the patient, client and regulators.
Serving as a Catalyst is what we do best. With strategic vision, expertise, and energy, we help clients generate and advance meaningful opportunities and solutions while side-stepping unnecessary challenges.
Our clients include biopharma, medical device, combination product, digital health and genomics companies, as well as patient advocacy organizations, venture capitalists launching new companies, and nonprofits. We specialize in helping cutting-edge companies identify the best pathways forward. And for those with regulatory policy agendas, we help to advance them.
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Latest News & Events
FDA User Fees, Drug Competition and Drug Pricing: Catalyst to Present on Regulatory and Legislative Vehicles for ChangeJune 12, 2017 / 0 Comments 0 Comments
Innovation and FDA’s Regulatory Frameworks: Catalyst Co-Authors Explore How the Coming Data Shift Will Impact Medical Product Regulation in Therapeutic Innovation & Regulatory Science ArticleMay 30, 2017 / 0 Comments 0 Comments
Former FDA Associate Commissioner Jill Hartzler Warner Joins Catalyst Team, Expanding the Firm’s Expertise in Regenerative Medicine, Rare Disease Drug Development and Combination Product RegulationApril 24, 2017 / 0 Comments 0 Comments
Latest Blog Posts
Megaphone Moment: FDA uses Exondys 51 Accelerated Approval to Prove Regulatory Flexibility and Value of Patient EngagementSeptember 19, 2016 / 0 Comments
We do what we love and love what we do. So what is that?
We build strategic action plans that drive the fast-moving regulatory environment, develop multiple options for our clients to engage and respond, and facilitate collaboration across key stakeholders.
Much of what we provide is a result of years of experience in DC – with FDA, trade associations, Capitol Hill and working closely with advocacy groups. We have the connections and the subject matter expertise to surface critical information quickly, using reliable sources to inform strategy development and business decisions.