FDA compliance starts with understanding which requirements apply to your products and how they enter the U.S. market.
We assist with FDA facility registration, U.S. Agent designation, product listings and other required filings for businesses manufacturing, importing or selling FDA-regulated products in the United States.
Registration is only one part of meeting FDA requirements.
Depending on the product and supply chain, FDA requirements may also affect labeling, manufacturing, distribution and importer responsibilities. We assist with Foreign Supplier Verification Program (FSVP) compliance, including the preparation of FSVP documentation and compliance programs, as well as other filings and procedural requirements that arise during the regulatory process.
Our assistance continues after the initial filing, including registration updates, renewals and other ongoing FDA compliance requirements.