Services
Each engagement starts with product category, sales channel, available records, and compliance objective.
Foreign establishments
A foreign facility registering with FDA must name a US agent. We provide the California address and a real person to receive FDA correspondence and pass it to you. The agent receives and relays; it does not answer FDA on your behalf.
Cosmetics
Facility registration and product listing preparation support for cosmetic brands.
Labels and claims
Review of required label elements, claim language, allergen statements, and category-specific risk points.
Marketplace risk
Review of titles, bullets, images, product pages, and claims that can create FDA-related marketplace risk.
Groundwork filings
FDA facility registration requires a Dun & Bradstreet D-U-N-S number, which a new foreign plant often does not have yet. A company importing in its own name also needs an EIN, and a foreign company without a US entity can use a CBP-assigned importer number instead. We handle these alongside the registration. An EIN does not require a US Social Security Number; international applicants cannot apply online and file by phone, fax or mail, and the phone line usually issues the number on the call. For clients setting up a US entity we also file the formation in the state you choose, and handle the EIN. We do not advise on which state to pick.
Food and supplements
Foreign food and dietary supplement facilities must register with FDA and renew every two years. In even-numbered years the renewal window runs from 1 October to 31 December, and a registration not renewed by then expires. Foreign facilities must also designate a US agent.