FDA Consulting
Guidehouse has been a trusted advisor to the U.S. Food and Drug Administration (FDA) for more than 20 years, providing technical solutions and scientific services that help the agency navigate increasingly complex drug, biologics, device, and food challenges. Our team operates at the intersection of operations, policy, science, and technology, helping the FDA solve today’s challenges and chart the future for innovation and growth.

We collaborate with the FDA to offer deep knowledge and expertise in regulatory science, clinical research, biomedical informatics, translational research, strategy, and operations. This business and scientific domain knowledge is paired with proven capabilities driving digital transformation and data-driven innovations.


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Our Services

Strategy & Innovation link-arrow

Our global perspective and local market knowledge offer public agencies a new understanding of their challenges when preparing for the future. Our operational and financial strategies and impactful innovations help clients achieve their goals and discover previously unseen opportunities.

Risk Management link-arrow

Our experts help FDA leaders continuously identify, analyze, assess, monitor, control, and mitigate loss exposure. We embed best practices into operations and provide tools and technical assistance to improve and sustain capabilities and capacity at all agency levels.

Digital Transformation link-arrow

We provide objective technology expertise to create a modern IT architecture integrating leading digital capabilities. With legacy solutions, constant demand for innovation, and cost pressure, we understand public agencies’ challenges. We provide end-to-end support to develop the roadmap to guide agencies through the digital transformation journey.

Change Management link-arrow

Understanding the importance of innovation in deploying data backed change management, our experts bring proven strategies to our engagements. Guidehouse’s (re)Vision™ change management process helps transform organizations across FDA and implement strategies through accelerated learning, training, and adoption.

Program Management link-arrow

We deliver proven expertise for complex program management needs through our TruePMOSM framework. This unique, integrated PMO methodology is tailored to FDA’s capabilities and goals to provide actionable insights and scalable technology, tools, and templates.

Workforce Transformation link-arrow

We assist FDA with developing data-driven strategies to understand the talent they need and develop recruitment strategies in today’s highly competitive employment market. This includes helping curate a distinctive employee experience that addresses burnout, resilience, and retention while creating the workforce of the future.

IT Strategy link-arrow

Guidehouse supports FDA at every step of transformation journey to help enable its future. Our agile IT strategies aid agencies in administration or removal of outdated solutions and legacy systems by consolidating systems and workflows in favor of more automated, innovative solutions.

Data Management link-arrow

We are a trusted advisor to FDA’s data modernization initiative, providing strategic and operational support. Our data management, visualization, learning and development, project/process management, operations, and IT architecture capabilities free leadership to focus on data-driven decision-making.

About Guidehouse Health

Ranked the nation’s third largest healthcare consultancy and IT consulting firm, Guidehouse Health integrates strategy and policy expertise with deep industry partnerships across the healthcare ecosystem, helping public sector and commercial health organizations deliver innovative services to their communities. Guidehouse supports all 15 executive departments of the U.S. federal government and such healthcare agencies as FDA, CDC, VA, CMS, HHS, IHS, MHS, and NIH. Guidehouse has received 19 KLAS #1 rankings and consistently attains higher performance ratings than other U.S. federal contractors.


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Complexity demands a trusted guide with the unique expertise and cross-sector versatility to deliver unwavering success. We work with organizations across regulated commercial and public sectors to catalyze transformation and pioneer new directions for the future.

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