FDA Made Easy

Join more than 30,000 companies who trust FDA Council as their comprehensive FDA compliance solution.

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FDA Council assists businesses with U.S. FDA compliance. FDA Council is not affiliated with the U.S. FDA.

What We Do

FDA Council has been a leading provider of FDA compliance assistance since 2003. Whether you’re in need of FDA registration, labeling compliance, or detention assistance, FDA Council is ready to assist.

FDA Registration

Owners or operators of all U.S. and non-U.S. drug establishments that engage in the manufacture, preparation, propagation, compounding, or processing of drugs are required to register and submit a list of every drug in commercial distribution in the United States.

FDA Labeling

FDA requires that drug labels be indexed using Extensible Markup Language (XML) in Structured Product Labeling (SPL) format. FDA Council can help modify your drug labeling to comply with FDA regulations. FDA Council provides revised graphic files ready to be printed or edited, and a report that details the regulations, compliance guides, warning letters, import alerts, and other guidance documents from FDA.

FDA Drugs

A Drug Master File is a submission to FDA that may be used in support of pre-market submissions to provide confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more drugs. FDA Council’s team of Regulatory Specialists provide guidance as to required elements, formats, and particularities of Drug Master File submissions.

Global Leader 10 Years In a Row

FDA Council may also assist with compliance in international markets.

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Trusted Experts

30,000 clients around the world trust us to keep them compliant and their data secure.

Choosing to assign our FDA registration to FDA Council was one of the best business decisions we made. Everything was done perfectly. They are always there to answer our questions and guide us through the complex paths of FDA Compliance. Dr. Nikolas Tsirikos

[FDA Council] was so patient, explaining the whole inspection process in detail, emphasizing our weaknesses, and answering all our questions during and after the visit. I would definitely recommend [FDA Council] to anyone who is about to face an FDA inspection. Manamim Food Industries

Labeling was a difficult process to get right and I could not have done it correctly without the help of [FDA Council]. They were very knowledgeable and easy to reach whenever I had a question. I highly recommend their services. Remarkable Imports, LLC

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+22 140 006 754

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