Expert FDA regulatory consulting for brands entering the US market. Fixed pricing, fast delivery, bilingual support.
We handle the regulatory complexity so you can focus on growing your brand.
Native English and Chinese service — no miscommunication, no delays.
No hidden fees. Know exactly what you pay before we start.
Most services delivered in 2–4 business days.
From classification to submission — we handle the full process.
Comprehensive regulatory support for cosmetics, supplements, medical devices, and food products.
Mandatory for all foreign companies selling in the US. Instant activation.
Ensure your product labels meet all FDA requirements before going to market.
Complete MoCRA registration for your cosmetics line, including facility registration.
Full support for medical device 510(k) premarket notification submissions.
See how we have helped Chinese brands navigate FDA compliance successfully.
A major Chinese cosmetics brand needed urgent MoCRA registration for their entire product line before a key US retail launch.
A supplement brand had their Amazon listings suspended due to missing FDA US Agent information.
A medical device startup needed rapid FDA registration number and predicate device identification.
A food manufacturer was placed on FDA's Import Alert list, blocking all US shipments.
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FDA Regulatory Advisor · KECC