Foundation in Regulatory Affairs (FRA)

Show the world that you have the foundational knowledge regulatory affairs professionals need. The new Foundation in Regulatory Affairs (FRA) assessment-based certificate is designed to help you build regulatory affairs knowledge and then test that knowledge through an exam.

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Prove you have the knowledge to start and succeed in regulatory affairs

The Foundation in Regulatory Affairs (FRA) is an assessment-based certificate that validates essential, early-career knowledge of regulatory affairs. The FRA pairs targeted regulatory education with an exam to validate what you have learned.

Earning the FRA shows employers and colleagues that you understand the fundamentals of regulatory affairs. It is a practical way to build confidence, demonstrate commitment, and stand out in a competitive job market.

Who is FRA for?

Early-career professionals seeking a recognized, foundational credential. No experience or pre-requisites are needed to sit for these exams.
Professionals transitioning into regulatory from other fields such as QA/QC, clinical operations, R&D, manufacturing, supply chain, labeling, marketing, or project management.
Students and recent graduates exploring regulatory career paths and seeking credible proof of baseline competency.
Teams and managers who want a consistent onboarding benchmark across regions and product lines.

Why Earn the FRA?

Validate essential regulatory knowledge. Demonstrate your understanding of foundational regulatory concepts, frameworks, roles, and responsibilities across the product lifecycle.
Accelerate onboarding and readiness. Help new hires ramp faster with a shared foundation, reducing training time and inconsistency across teams and regions.
Support career mobility. The FRA helps professionals pivot into regulatory roles and align with global expectations for entry level regulatory professionals.
Signal commitment to the profession. Earning a credential communicates dedication to professional standards and continuous learning.

FRA Credentials

The FRA offers four credentials aligned with key regulatory areas:

Medical Devices
- FRA: Introduction to Medical Devices
- FRA: Global Regulatory Strategy for Medical Devices
Pharmaceuticals
- FRA: Introduction to Pharmaceuticals
- FRA: Global Regulatory Strategy for Pharmaceuticals

FRA: Introduction to Regulatory Affairs

Build a strong foundation in regulatory affairs and gain a shared professional language by exploring:

Healthcare products and the regulatory lifecycle
Regulatory frameworks in the U.S. and Canada
Foundational regulatory systems in the European Union

Learn More

FRA: Global Regulatory Strategy

Build a global regulatory perspective by understanding how regulations vary across regions and how to navigate them by exploring:

Global regulatory systems and authorities
Foundational global regulatory strategies
Core submission and lifecycle activities globally

Stay tuned for more details coming soon!

How the FRA differs from the RAC

The FRA is an assessment-based certificate focused on verifying basic knowledge for early-career professionals and those transitioning into regulatory affairs. It confirms understanding of fundamental concepts and shared professional language. The exam questions focus on basic recall to ensure you have a good grasp of key facts.

The Regulatory Affairs Certification (RAC) is a professional certification for experienced practitioners who apply regulatory knowledge to complex, real-world scenarios. The RAC is widely recognized as a benchmark for advanced proficiency and strategic impact. The exam questions focus on application to test your ability to apply regulatory concepts.

The FRA is a confidence-building, résumé-ready credential that prepares you to grow toward the RAC and other advanced professional goals.

Learn the key difference between a certificate and a certification and which option is right for you.

Still have questions? Read the FAQs.