We focus on FDA regulations, so you can focus on your business
Providing expertise in FDA and USDA legislation for pre-market and post-market businesses.
Are you in trouble with the FDA?
Don’t panic — you’ve got backup. Download 5 Tips to Help You Navigate FDA Enforcement and learn how to resolve the situation now.
See your ideas come to life without fear of government violations or lawsuits
The FDA landscape is complicated, and there are hundreds of complex rules and regulations that require detailed attention.
With extensive experience working within the FDA ecosystem, we ensure our clients achieve compliance at every stage.
Here’s how we help
Getting FDA Approval
Pre-market businesses and entrepreneurs in highly regulated industries like food and beverage, CBD, medical device, OTC drugs, supplements, cosmetics, and tobacco have a lot of red tape to navigate.
From label reviews to advertising reviews, permits to approvals, we can help.
Solving FDA Problems
Have you received an FDA Warning Letter or run into trouble with inspections and imports? FDA Atty can provide your business with sound advice so you can come to a favorable resolution and continue growing your business.
Don’t delay, because time is of the essence.
Lending Expertise and Mediation
FDA Atty partners with other law firms, offering expertise in FDA and USDA legislation and answering complex regulatory questions.
Serving as an FDA litigation adviser, expert witness, or mediator, we help your clients find resolutions to their cases.
“
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.
Secure your future on our foundation of FDA expertise
FDA Atty is a boutique law firm focusing solely on FDA and USDA regulations, representing clients in the food, dietary supplement, beverage, cosmetic, medical device, and drug industries.
With over a decade of experience, we provide sage advice in real-world terms—so you can be sure you’re making the best decisions for your business.
Marc C. Sanchez Esq. FDA Attorney
“
As the medical director of a small bioenergetic medicine “device” company, we engaged Mr. Sanchez to help us with regulatory actions taken by the FDA. While it was a long, drawn-out process that culminated in a visit to Washington, we ultimately got the problem solved. I learned two things from this process—that you can’t deal with these issues without a lawyer, and that Marc Sanchez is good at what he does. He is ethical, sharp, street smart and mindful. Hire him.”
-Dr. Richard Nahas Ergopathics Canada
Services
Regardless of the issue you’re dealing with, we’re here to help. Click on the service below to get more information on how FDA Atty can protect your business from regulatory violations.
FDA Problems
Import
Inspections
Warning Letters
Recalls
Consent Decree and DOJ Injunction
Lending Expertise and Mediation
Industries
Food & Beverage
Supplements
Drug
Medical Device
Cosmetic
Tobacco and E-Cigarette
Animal
Want Peace Of Mind?
Make sure your business is compliant with FDA legislation now — and in the future.
