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FDA Compliance

At The Law Office of Katherine Giannamore, P.A, we are committed to providing comprehensive regulatory assistance to individuals and companies throughout the United States and abroad. Focused on Food, Drug & Cosmetic Law (often referred to as “FDA law”), our practice is dedicated to providing regulatory guidance to a wide variety of clients who are in need of assistance with establishing and maintaining full compliance with federal laws and regulations, including FDA compliance, as well as FTC and USDA compliance.

Both start-up operations and established companies alike count on us to provide thorough legal assistance to ensure conformity with federal regulatory authorities, including the U.S. Food and Drug Administration (“FDA”), the Federal Trade Commission (“FTC”) and the U.S. Department of Agriculture (“USDA”).

FDA Compliance and Regulatory Guidance

Establishing and maintaining FDA compliance with respect to the following:

  • Foods
  • Beverages
  • Cosmetics
  • Dietary Supplements
  • Drugs
  • Medical Devices
  • Over-the-Counter (OTC) Drugs

FDA Compliance and Regulatory Services

At The Law Office of Katherine Giannamore, P.A., we assist our global clientele with a wide range of regulatory issues, including premarket notifications, or 510(k) submissions, removals from import alerts, reconditioning requests, responses to warning letters and a number of other services. More information about the types of services we provide may be accessed here.

In order to help individuals establish compliance with federal laws and regulations at the outset, we also provide reviews of products and marketing materials to ensure that these products are compliant with federal laws before they are marketed and sold in the United States. These reviews include ingredient and label reviews for many different  types of products in all FDA-regulated industries. Some of the FDA-regulated products that we provide assistance with are foods, dietary supplements, medical devices, cosmetics and over-the-counter (OTC) drugs.

For more information about FDA compliance and related regulatory assistance or how a FDA regulatory attorney may help you, contact us at contact@giannamore-law.com.

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