Entering or maintaining compliance in the U.S. market can’t be very complicated, but it doesn’t have to be. Our FDA regulatory services help businesses meet U.S. requirements for dietary supplements, food, cosmetics, drugs, medical devices, ingredients, and more.
Expanding into the U.S. market offers exciting opportunities, but strict FDA rules can make the process challenging. Companies often deal with unclear requirements, shifting regulations, and tight timelines.
That’s where we step in. With straightforward steps and practical support, you can navigate regulations with clarity and know you’ll be supported every step of the way.
We provide a complete range of FDA compliance solutions designed to guide you through the challenges of entering and operating in the U.S. market. From complex registrations to detailed submissions and product reviews, our role is to make the process clear and straightforward so you can move forward.
Whether you are entering the U.S. for the first time or expanding your product lines, our team helps you navigate FDA compliance with confidence.
Since 2007, we have supported more than 3,500 clients across industries. From small companies entering the U.S. for the first time to established global brands, our experience reflects our ability to deliver reliable, compliant solutions.
Yes. FDA requires a U.S. agent for foreign companies to act as their point of contact. We provide this service to ensure smooth communication with FDA.
GRAS (Generally Recognized as Safe) applies to food ingredients considered safe under expert consensus, while NDI (New Dietary Ingredient) applies to substances in supplements requiring FDA notification. We help determine the right path for your ingredient.
Timelines vary depending on the product type, but registrations often take weeks to a few months. With our support, you’ll be prepared with accurate documentation to avoid delays.
Yes. We assist with initial registrations, submissions, and ongoing requirements like renewals and reporting.
Cosmetic products do not require pre-market approval, but facilities and products must be properly listed, and labelling must comply with FDA requirements.
A 510(k) is a premarket submission to FDA demonstrating that a medical device is safe, effective, and substantially equivalent to an already legally marketed device.
An NDIN is required when a dietary supplement contains an ingredient not marketed in the U.S. before October 15, 1994. We prepare and submit NDINs to meet FDA standards.
An NDIN is required when a dietary supplement contains an ingredient not marketed in the U.S. before October 15, 1994. We prepare and submit NDINs to meet FDA standards.
Stay informed on FDA changes that may affect your business. Explore our latest articles for practical guidance and updates.
Let’s make your FDA compliance journey clear and achievable. Our team is ready to support your next steps.
