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.

Click here to learn more about our leadership team.

Catalyst Strategic Launch Solutions. Concept to Market. FDA Policy & Submission Pathway Consulting. Legislative Landscape. Networking with Thought Leaders. Message Development & Communications. Policy Development. Meaningful Patient Engagement. Regulatory Intelligence & Landscape Analysis. Incorporating Payor Perspective. Effective Trade Association Engagement.

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Latest News & Events

September 27, 2017

Commissioner Gottlieb, CAR T-Cells, & The Future Of Rare Disease Therapies

September 27, 2017 / 0 Comments 0 Comments
Pharmaceutical Online-  What do Commissioner Gottlieb’s recent statements on orphan drug innovation—coupled with the FDA’s first gene therapy approval this summer (for the CAR T-Cell therapy, Kymriah)—mean for the industry?… read more →
August 23, 2017

The Changing Regulatory Landscape Under Gottlieb and Trump: Catalyst Featured as Part of Expert Panel Webinar Series

August 23, 2017 / 0 Comments 0 Comments
Catalyst VP-Regulatory Policy and ex-FDAer Jill Hartzler Warner, JD, will analyze the changing regulatory environment for biopharma and device companies as part of an FDANews expert panel series this Fall.… read more →
June 12, 2017

FDA User Fees, Drug Competition and Drug Pricing: Catalyst to Present on Regulatory and Legislative Vehicles for Change

June 12, 2017 / 0 Comments 0 Comments
On June 13, Catalyst President Nancy Bradish Myers will present on PDUFA and other user fee agreements, and their impact on drug competition. Ms. Myers will be a featured speaker… read more →
May 30, 2017

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 Article

May 30, 2017 / 0 Comments 0 Comments
Given rapid advances in technology and our understanding of disease, the future will bring a shift in how the health care system thinks about and uses data, Michael Doherty, Foundation… read more →

Latest Blog Posts

We do what we love and love what we do. So what is that?

Catalyst Healthcare Consulting, Inc. scans the regulatory, policy, political, and stakeholder environments to create comprehensive strategies that achieve our clients’ objectives. We draw from our experience across the spectrum of healthcare stakeholder organizations; through direct interactions with the FDA, CMS and other federal agencies, we help to advance our clients’ agendas. We also keep a finger on the policy pulse of Capitol Hill, and offer a general enhanced understanding of goings-on in DC.

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.

Our regulatory intelligence gathering is designed to inform corporate strategy. Our relationships and position within DC enable us to serve as an early warning system for policy developments that create opportunities or signal challenges that could affect your organization’s pipeline/products or objectives. 

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.

Maximizing current and future policy opportunities requires precision. We work in partnership with our clients to extract the signals from the noise, and develop and implement on-point, targeted approaches that harness emerging policy issues to advance our clients’ goals.
With the vast array of stakeholder voices involved in health policy, we are here to ensure your voice is heard. We create policy options that support our clients’ objectives, as well as those of FDA or other federal agencies.  Both in the US and internationally, Catalyst helps to shape policies as they develop.
Identification of, and cooperation with, allies is key to maximizing opportunities, given the many players converging to form emerging health policy. We facilitate collaboration and networking opportunities across the healthcare spectrum: between and among industry, patient and consumer advocacy groups, professional organizations and academics.

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