FDA US Agent
US Agent designation and correspondence workflow for foreign establishments.
Review scopeUS FDA market-entry compliance
Regulatory support for brands entering the United States.
A practical compliance desk for international companies preparing FDA US Agent, MoCRA, label review, Amazon compliance, and 510(k) readiness work.
Positioning
The service is FDA compliance clarity, not brand theater.
The site is organized around regulatory workstreams. The operating company is KECC Consulting LLC, but the front door is the problem clients actually search for: US FDA compliance support for market entry.
Core services
Market-entry support by product and risk area.
MoCRA cosmetics
Facility registration, product listing preparation, and label readiness support.
Review scopeLabel review
Structured review of labels, claims, required statements, and category-specific risk.
Review scopeAmazon compliance
Review marketplace claims, images, and product language that can trigger FDA-related risk.
Review scopeService matrix
What the compliance desk can handle.
| Service | Best for | Typical deliverable | Timeline | Starting fee |
|---|---|---|---|---|
| FDA US Agent | Foreign facilities | Agent designation and correspondence workflow | 1 business day | $499/year |
| Label review | Supplements, food, cosmetics | Written label and claims review | 2 business days | $299/SKU |
| MoCRA package | Cosmetic brands | Registration and listing preparation | 4 business days | $899 |
| 510(k) readiness | Device teams | Classification and submission readiness review | Scoped after intake | Custom |
Need clarity?