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.

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Latest News & Events

November 22, 2016

FDA Under Trump: What To Expect, and Why the Unique Nature of FDA Should be Considered by the Transition Team – Catalyst Guest Column

November 22, 2016 / 0 Comments 0 Comments
Life Science Leader – Trump’s advance team will soon be headed to FDA’s White Oak campus to observe and learn, as planning unfolds for the transition to the new Administration.… read more →
August 10, 2016

Video: Watch Catalyst’s Nancy Myers Discuss the Future of Big Data

August 10, 2016 / 0 Comments 0 Comments
Catalyst President Nancy Bradish Myers and fellow Big Data panelists took time out from the DIA annual meeting to talk about how Big Data is transforming drug development and health… read more →
June 29, 2016

Press release:
The Future of Big Data: Quality Standards, Importance of Collaboration Emerge as Themes in Catalyst-Moderated Panel at DIA

June 29, 2016 / 0 Comments 0 Comments
Philadelphia, PA, June 29, 2016 – The future of Big Data, while promising, will depend on the ability of stakeholders to come together and collaborate to develop quality standards for… read more →
June 9, 2016

DIA 2016: Big Data “DIAmond Session” Moderated By Catalyst Will Explore Innovations That Will Both Generate and Harness Big Data to Disrupt the Health Care System

June 9, 2016 / 0 Comments 0 Comments
Just how BIG will Big Data be? Come hear from top thought-leaders about the coming “data tsunami,” and the innovations in the pipeline that will both generate and harness Big Data to… 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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