Compliance Coast to Coast

We offer trusted guidance and expertise so you can make the best decisions for your business.

About Map

This isn’t your run-of-the-mill law firm

At FDA Atty, we pride ourselves on making sure our clients feel comfortable and empowered at every stage of our engagement. Our long-standing experience in FDA regulations enables us to offer you sound legal advice, so you can protect your business now and in the years to come.

Here’s what gives us—and our clients— a distinct advantage:

FDA Expertise

With over a decade of experience working with the FDA, we have a proven track-record of successfully navigating the rules and regulations to help our clients stay compliant.

High-Touch Process

FDA legislation is intimidating and anxiety-inducing for many business owners. We personally guide you through every stage so you have peace of mind.

FDA Familiarity

We have built many connections within the FDA. This helps us quickly connect with appropriate personnel to ensure our clients’ questions are seen and heard.

Cross-Industry Knowledge

We serve a wide range of clientele in the food, dietary supplement, beverage, cosmetic, medical device, and drug industries, located across the globe.

Entrepreneurial Background

We are business owners too. This means we bring a unique perspective to the table, balancing the importance of gaining market share while meeting regulations.

Client Empowerment

Knowledge is power. We focus on offering expertise in understandable terms so you feel confident about where your business is headed.

Find relief knowing your business is in good hands. When you work with us, you’ll have an FDA expert by your side — every step of the way.

Our practice is focused on helping pre-market and post-market entrepreneurs run small and medium businesses

Certificate

Getting FDA Approval

We help you navigate label reviews, permits, approvals, ingredient reviews and more as you launch your business.

Puzzle Piece

Solving FDA Problems

From issues with imports to inspections, Warning Letters to recalls, we help find resolutions so you can grow your business.

Shaking Hands

Lending Expertise and Mediation

Working as a litigation adviser, expert witness, or mediator, we offer specialized knowledge for your firm and clients.

Meet Marc C. Sanchez, Esq., Senior Counsel

Marc is dedicated to helping his clients navigate the complex world of FDA and USDA legislation.

Marc represents FDA-regulated companies in the food, dietary supplement, beverage, cosmetic, medical device, and drug industries. With a broad depth of experience, he advises clients on the regulatory requirements and strategic corporate considerations that affect the importation, distribution, and exportation of FDA-regulated products.

Marc is a frequent national speaker on FDA compliance issues affecting the food, dietary supplement, and medical device industries. He is also considered a leading voice in understanding the Food Safety Modernization Act, which has fundamentally changed food law in the U.S., with interviews and contributions in the Washington Post and Huffington Post.

Marc is the author of two textbooks, including Springer International’s first food law text, now in its 2nd edition. He is also a lecturer at Northeastern University.

Marc is a member of the Washington State Bar Association and the D.C. Bar Association. His practice is limited to matters and proceedings before the United States Food & Drug Administration.

Meet Marc C. Sanchez, Esq., Senior Counsel

Marc is dedicated to helping his clients navigate the complex world of FDA and USDA legislation.

Marc represents FDA-regulated companies in the food, dietary supplement, beverage, cosmetic, medical device, and drug industries. With a broad depth of experience, he advises clients on the regulatory requirements and strategic corporate considerations that affect the importation, distribution, and exportation of FDA-regulated products.

Marc is a frequent national speaker on FDA compliance issues affecting the food, dietary supplement, and medical device industries. He is also considered a leading voice in understanding the Food Safety Modernization Act, which has fundamentally changed food law in the U.S., with interviews and contributions in the Washington Post and Huffington Post.

Marc is the author of two textbooks, including Springer International’s first food law text, now in its 2nd edition. He is also a lecturer at Northeastern University.

Marc is a member of the Washington State Bar Association and the D.C. Bar Association. His practice is limited to matters and proceedings before the United States Food & Drug Administration.

Get rid of non-compliance risks so you can focus on growing your business.

Marc has been helping my company for almost 2 years with various FDA medical device compliance issues. Most recently, after exhaustive work on both Marc’s and our part, we successfully obtained our 510k clearance! Marc is knowledgeable, dedicated, thorough, and doesn’t give up fighting for his clients. I HIGHLY recommend Marc.”

-Thomas Kraft, Partner Uplevity Inc.