Food & Beverage Services At a Glance
| Service | Who Needs It | Frequency | Timeframe | Pricing Starting at |
|---|---|---|---|---|
| U.S. Agent Services | Foreign facilities only | Annual | Before FDA registration; renew each year | $295/yr |
| Food Facility Registration | Domestic & foreign | Biennial | Oct Dec of even-numbered years | $249 |
| Prior Notice (Imports) | Foreign importers | Per unique product line | Before arrival at U.S. border | $30/filing |
| Food Label Review | All manufacturers | Per product/change | Before market entry or label change | $249/product |
| Dietary Supplements | Supplement manufacturers | Biennial + ongoing | Oct Dec biennial; NDI notification 75 days prior | $249 |
| Animal & Veterinary | Pet/animal food facilities | Biennial | Oct Dec of even-numbered years | $249 |
Drugs & Pharma Services At a Glance
| Service | Who Needs It | Frequency | Timeframe | Pricing Starting at |
|---|---|---|---|---|
| U.S. Agent Services | Foreign facilities only | Annual | Before FDA registration; renew each year | $295/yr |
| Drug Establishment Registration | Domestic & foreign | Annual | October-December of each year | $449/yr |
| Drug Product Listing (NDC) | All drug manufacturers | Annual + per change | At registration; updated when products change | $299/product |
| Structured Product Labeling (SPL) | All drug manufacturers | Per submission | At listing submission & with each label update | $249/submission |
| Drug Label Review | All manufacturers | Per product/change | Before market entry or label revision | $449/product |
| Animal & Veterinary Drugs | Vet drug manufacturers | Annual | October-December of each year | $449/yr |
Cosmetics Services At a Glance
| Service | Who Needs It | Frequency | Timeframe | Pricing Starting at |
|---|---|---|---|---|
| U.S. Agent Services | Foreign facilities only | Annual | Before facility registration; renew each year | $295/yr |
| Cosmetic Facility Registration | Domestic & foreign | Biennial | Initial registration required; renewal every 2 years | $449 |
| Cosmetic Product Listing | All cosmetic brands | Annual + per product | Within 120 days of marketing; updated every year | $299/product |
| Cosmetic Label Review | All manufacturers | Per product/change | Before market entry or reformulation | $449/product |
| Responsible Person Consulting | Foreign brands | Ongoing | Required before marketing in the U.S. | Contact Us |
Medical Device Services At a Glance
| Service | Who Needs It | Frequency | Timeframe | Pricing Starting at |
|---|---|---|---|---|
| U.S. Agent Services | Foreign facilities only | Annual | Before FDA registration; renew each year | $295/yr |
| Device Establishment Registration | Domestic & foreign | Annual | October-December each year | $349/yr |
| Medical Device Listing | All device companies | Annual | At registration; updated annually October-December | $50/device |
| Structured Product Labeling (SPL) | Device establishments | Per submission | At listing & with each labeling update | $249/submission |
| Device Label Review | All manufacturers | Per product/change | Before market entry or label revision | $449/product |