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:
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.
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.
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.