The Law Office Of Katherine Giannamore, P.A

Shehadeh Giannamore, PLLC is a dedicated firm specializing in providing comprehensive legal and regulatory guidance for businesses navigating the complex landscape of the Food and Drug Administration (FDA). We understand the intricate web of federal laws and regulations governing a multitude of industries, from food and beverages to cosmetics, dietary supplements, and medical devices. With a team of seasoned legal professionals, we are committed to empowering our clients with the knowledge and support they need to achieve and maintain FDA compliance.

Our firm's legacy is built upon a foundation of experience, expertise, and a unwavering commitment to client satisfaction. We pride ourselves on offering accessible, practical, and results-oriented legal solutions tailored to the unique needs of each client. Whether you are launching a new product, expanding into new markets, or facing regulatory hurdles, we are your trusted partner in navigating the FDA regulatory environment.

A Broad Spectrum of FDA Compliance Services

At Shehadeh Giannamore, PLLC, we offer a comprehensive suite of services designed to address every facet of FDA compliance. Our expertise encompasses a wide range of industries and product categories, ensuring that we possess the specialized knowledge required to provide effective solutions for your specific needs.

Ingredient and Label Reviews: Before introducing a new product to the market, it is crucial to ensure that its ingredients and labeling are in full compliance with FDA regulations. Our team of experts conducts meticulous reviews of both ingredients and labeling content, identifying potential non-compliance issues and recommending necessary changes to ensure a smooth regulatory pathway.

Premarket Notifications (510(k) Submissions): For medical devices, premarket notifications are vital for obtaining FDA clearance. We guide our clients through the complex 510(k) submission process, meticulously preparing and submitting all required documentation to ensure a timely and successful approval.

FDA Registrations: Maintaining accurate and up-to-date FDA registrations is essential for all businesses manufacturing, distributing, or importing regulated products. Our team assists with the registration process, ensuring compliance with all applicable requirements.

Dietary Supplement Expertise: We specialize in providing comprehensive legal and regulatory guidance for dietary supplement manufacturers, importers, and marketers. Our services encompass 30-day notifications, structure/function claim substantiation, and navigating the complex regulatory framework governing these products.

Warning Letter Responses: Should your business receive a warning letter from the FDA, it is crucial to respond promptly and effectively. Our attorneys possess extensive experience in drafting comprehensive and persuasive responses that mitigate the potential consequences of an FDA warning.

Beyond Compliance: Building Brand Value

At Shehadeh Giannamore, PLLC, our commitment to our clients extends beyond mere compliance. We recognize that navigating FDA regulations can be complex and demanding, often requiring a deep understanding of both legal and business considerations. Our team works collaboratively with our clients, providing not only legal expertise but also strategic guidance to help them achieve their business objectives while upholding the highest standards of regulatory compliance. We believe that true success in the FDA-regulated environment is achieved through a partnership built on trust, transparency, and a shared commitment to excellence.