FDA Attorneys & Consultants
Regulatory lawyers providing expertise in FDA and USDA legislation for pre-market and post-market businesses.
We focus on FDA regulations, so you can focus on your business.
Are you in trouble with the FDA?
Don’t panic — you’ve got backup. Our FDA lawyers have worked with FDA regulations in a range of industries for over a decade, and know how to fix any problem now and keep it from happening again.
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. We understand how critical it is to be able to focus fully on your business without having to worry about FDA regulation violations.
Our regulatory attorneys at FDA Atty have extensive experience working within the FDA ecosystem, and ensure our clients achieve compliance at every stage. Our FDA lawyers have worked with clients in a range of industries to provide expert advice and peace of mind.
Here’s how we help
Getting FDA Approval
Pre-market businesses and entrepreneurs in highly regulated industries like food and beverage, CBD, medical devices, OTC drugs, supplements, cosmetics, and tobacco have a lot of red tapes to navigate.
Our highly experienced regulatory lawyers understand that your products can make a difference in the lives of your customers, and will work to ensure they get them on the market. From label reviews to advertising reviews, frequently requested approvals such as PMAs, 501ks, and PMTAs, we can help with our team of FDA Attorneys.
Solving FDA Problems
Have you received an FDA Warning Letter or run into trouble with inspections and imports? Don’t panic! Our FDA Attorneys at law 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. Get help from our highly experienced regulatory attorneys regardless of your industry. We can assist you with imports, inspections, warning letters, recalls, or anything else post-market enforcement-related.
Medical Device Regulatory Services
FDA Atty helps medical device companies navigate FDA requirements from early product strategy through submission, clearance, and post-market compliance. We advise device companies on regulatory pathways, labeling, FDA communications, quality-system expectations, and compliance risks.
Whether you are preparing a 510(k), evaluating a De Novo or PMA pathway, responding to FDA questions, or trying to understand how your product may be classified, our team provides practical legal guidance grounded in FDA regulatory experience.
Read what our clients have to say about us
“
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. Dedicating our work entirely to FDA and USDA enforcement has allowed us to develop specialized knowledge in the area.
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. Our FDA lawyers serve clients across the US and around the world, providing regulatory expertise, market-focused service, cross-industry insight, and approachable and available counsel.
Marc C. Sanchez Esq. FDA Attorney
510(k), eSTAR, and FDA Submission Support
Medical device submissions require more than filling out forms. FDA expects a clear regulatory strategy, accurate device classification, appropriate predicate analysis, well-supported testing, and submission materials that address the agency’s review standards.
FDA Atty assists with 510(k) submissions, eSTAR preparation, De Novo strategy, FDA pre-submissions, device classification questions, labeling review, and responses to FDA deficiencies. We help companies understand what FDA is likely to ask for before time and money are spent in the wrong direction.
Services
FDA Atty has over a decade of experience advising clients on FDA and USDA regulations. We have assisted clients in a variety of industries with their FDA compliance issues, and we have also partnered with other law firms and assisted in building a winning strategy for their clients.
Regardless of the issue you’re dealing with, we’re here to help. Click on the service below to get more information on how our FDA Attorneys can protect your business from regulatory violations.
Want Peace Of Mind?
Make sure your business is compliant with FDA legislation now — and in the future.
Stay up to date with FDA and USDA regulations
In their capacity as regulatory attorneys, our team at FDA Atty is deeply committed to not only providing FDA and USDA legal counsel services but also keeping our clients informed about industry regulations that may affect their business.
Through our blog, we will fill you in on FDA and USDA news and we will also provide insight into certain industry-specific topics you might find helpful.
