About Us

FDA Council helps companies comply with United States Food and Drug Administration (FDA) regulations quickly and properly.

FDA Council was founded in 2003 to help businesses comply with U.S. Food and Drug Administration (FDA) regulations. Since opening its headquarters in Hampton, Virginia, USA, FDA Council has expanded to 20 worldwide offices and has aided more than 30,000 companies across 160 countries. Employees include former U.S. FDA officials, scientists, and industry experts.

FDA Council offers FDA compliance assistance for the following industries:

FDA Council has been a leading provider of FDA compliance assistance since 2003. Our services are always provided for a low fixed-fee, never by the hour. Our multilingual Regulatory Advisors are available 24 hours a day to answer your questions via our Online Live Help. Whether you’re in need of FDA registration, labeling compliance, or detention assistance, FDA Council is ready to assist.

Education and Outreach

The FDA regulatory landscape is constantly changing as FDA releases new rules and guidance documents. FDA Council is committed to keeping industry educated on the latest FDA requirements through blogs, trade shows, seminars, webinars, and various other outreach. Our Regulatory Specialists review every regulation thoroughly and communicate with FDA regularly to ensure full understanding of the Agency’s expectations of industry.

Software Solutions

FDA Council provides a variety of software solutions to aid in compliance with FDA requirements.

FDA COMPLIANCE MONITOR

A tool to help food facilities and importers evaluate their suppliers’ FDA compliance and approve suppliers, as required under FSMA.

FCE WIZARD

Determine whether products may be subject to FDA FCE-SID requirements.

PRIOR NOTICE EXPRESS

Prior Notice must be submitted to FDA for each food, beverage, or supplement shipment to the USA. Our Express service makes submitting Prior Notice quick and easy.

 

400k+ Satisfied Customers

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“Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore.  When an unknown printer took a galley of type and scrambled it to make a type specimen book.” Sara Blankenship