Strengthening Regulatory Expertise with Former FDA Leadership

At J&B Consulting, we are committed to providing practical, reliable, and up-to-date U.S. regulatory consulting services. To further strengthen our expertise, we are pleased to welcome Dan Simonsen, a former FDA Officer with more than 17 years of regulatory and compliance experience, to our consulting team.

Throughout his career at the U.S. Food and Drug Administration (FDA), Dan participated in regulatory reviews, compliance activities, and inspections across a broad range of FDA-regulated products. His firsthand experience provides valuable insight into how FDA regulations are interpreted and applied in real-world situations.

Practical Regulatory Guidance Beyond the Regulations

Many regulatory questions cannot be answered by simply reading the regulations. Companies often encounter situations where:

• FDA guidance appears unclear or open to interpretation

• Regulations do not fully address a specific business scenario

• Multiple regulatory pathways may exist

• A practical understanding of FDA expectations is required before making important business decisions

These are the situations where experienced regulatory judgment becomes especially valuable.

By combining J&B Consulting's regulatory consulting experience with the practical perspective of a former FDA Officer, we can provide more comprehensive, practical, and reliable regulatory support for our clients.

Areas of Consultation

Our Former FDA Advisory Service is available for:

• Cosmetics

• Food

• Dietary Supplements

• Over-the-Counter (OTC) Drugs

• Medical Devices

• FDA Import Alerts

• FDA Regulatory Strategy

• Compliance Reviews

• Regulatory Interpretation and Clarification

• Product Classification

• Labeling and Regulatory Compliance

Why This Matters

Regulatory decisions often involve more than checking whether a regulation exists—they require understanding how FDA evaluates compliance in practice.

With direct access to former FDA expertise, we are able to provide clients with:

Practical regulatory interpretations

Clear guidance on complex compliance questions

Strategic recommendations based on real FDA experience

Greater confidence when navigating U.S. regulatory requirements

We're Here to Help

Whether you are launching a new product, responding to a regulatory inquiry, reviewing labeling, or facing a complex compliance issue, our team is here to support you.

If you have questions about U.S. FDA regulations or would like to discuss your project, please feel free to contact J&B Consulting.

We look forward to helping your business navigate the U.S. regulatory landscape with confidence.

Contact Today: info@jnbfoodconsulting.com  / 714-873-5566