Dispositivos Médicos
US Agent Service
FDA-mandated US Agent representation for foreign medical device companies operating in the US market.
510(k) Application
Full support for your 510(k) premarket notification submission to the FDA.
510(k) Exempt – Justification Letter
Official justification letter confirming your device qualifies for 510(k) exemption.
Official Product Classification – Justification Letter
Device classification letter for USA, Argentina, Brazil, Peru and other markets.
Establishment Registration & Listing
FDA Establishment Registration and Device Listing for foreign manufacturers.
Medical Device Registration – Argentina (ANMAT)
New registration, renewal or amendment for medical devices before ANMAT.
Medical Device Registration – Brazil (ANVISA)
New registration, renewal or amendment for medical devices before ANVISA.
Hosting Brazil
Brazilian regulatory hosting services for foreign medical device companies.
Cosméticos
US Agent – Cosmetics
FDA-mandated US Agent representation for foreign cosmetic companies under MoCRA.
Ingredient Review
Full ingredient compliance review under FD&C Act and 21 CFR.
Label Review
Complete label compliance review per 21 CFR Part 701.
MoCRA Implementation
Full MoCRA compliance implementation — Facility Registration, Product Listing and US Agent designation.
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