Manage your risk while increasing market share
FDA expertise for pre-market label reviews, permits, frequently requested approvals such as PMAs, 510k, PMTAs, and more.
Taking your business to the next level while remaining compliant is no easy feat
Your products can make a major difference in the lives of your customers, but getting them to market and ensuring they stand out against the competition is challenging when you have to keep FDA rules and regulations in mind.
Without detailed knowledge of FDA regulations, it’s hard to know what you can and cannot say on your labels and marketing materials, or when you need FDA approval. You need an experienced advocate who can help you navigate the guidelines while mitigating risk.
We take the worry out of getting your products to market.
Sage advice on FDA rules and regulations for pre-market entrepreneurs
Are you launching a new product or campaign, or looking to get your products in with major retailers? Ensure your product — and all the paperwork — is in compliance with FDA legislation so you can secure the next step in your business journey.
There are subtle differences between a cosmetic claim and a drug claim. FDA Atty walks you through the language you can use to stay compliant.
We help you understand the scope of regulations, as well as ensure your labels, point-of-purchase material, and claims are compliant.
Non-prescription or OTC drugs and homeopathic drugs must follow tough FDA restrictions. We help you navigate the classification system, label reviews, export certificates, and more.
Veterinary products for pets and animals for human consumption are categorized into two areas by the FDA. We ensure your claims and your categorization are accurate.
From label reviews to advertising reviews, we offer a broad range of legal and regulatory services for product manufacturing and marketing.
There is a maze of new regulations for tobacco products, vapes, and e-cigarettes. We assist with approval, health document submissions, labeling requirements, and more.
From product clearance and approval to post-market requirements, there is a lot to consider when you develop and market a medical device. We show you how.
Experience the FDA ATTY Difference
Regulatory expertise
We bring over a decade of experience working directly within the FDA landscape, so we can help you mitigate risk while ensuring your products stand out from the crowd.
Cross industry insight
Experienced in OTC drug, supplements, food and beverage, cosmetics, and more, we’re familiar with the rules and regulations that apply specifically to your business.
Market-focused
Getting your products approved is one thing, but you also need to showcase their originality to the public. We help you understand the boundaries of what language is permitted by the FDA.
Approachable and available
At FDA Atty, you have access to senior counsel when you need it. Whether you have a question or issue, we’re available to walk you through it so you feel confident in your decisions.
Here’s how to get started
- Book your free 20-minute consultation: We’ll get to know your business and share our knowledge of the related FDA legislation.
- Develop your regulatory strategy: We work together to create an action plan on how you can get your products approved by the FDA and noticed by your customers.
- Gain market share while ensuring compliance: We help you manage your risk by sharing how you can use language carefully on packaging and marketing.
Expert knowledge of FDA regulations that helps you strategically grow your business
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