Regovant LLC

Regovant LLC is a U.S.-based FDA regulatory services firm helping international manufacturers and exporters bring their products into the United States in full compliance with FDA requirements. We act as a designated U.S. Agent and provide end-to-end support for FDA registration, communication, and regulatory compliance.

Our core services include FDA Food Facility Registration, U.S. Agent services, Medical Device Establishment Registration and Listing, Drug Establishment Registration, Cosmetic MoCRA compliance, label review, and regulatory consulting. We also provide export/import compliance support including FDA Prior Notice filing for food shipments and FSVP (Foreign Supplier Verification Program) setup for U.S. importers under FSMA requirements.

Additional services include FCE registration, SID filing, UDI compliance, 510(k) support, DMF submissions, and Certificate of Free Sale, depending on product category requirements.

Transparent Pricing (USD):

• FDA Food Facility Registration + U.S. Agent: from $269/year
• Medical Device Registration & U.S. Agent: from $369/year
• Drug Establishment Registration & U.S. Agent: from $369/year
• Cosmetic (MoCRA) Registration: from $369/year
• FDA Prior Notice Filing: $25 per shipment
• FSVP Setup: from $369 per importer

With 600+ clients across 49 countries, Regovant is trusted for its fast turnaround, transparent pricing, and reliable compliance support. We begin work within one business day and provide structured guidance tailored to each product category.

Headquartered in Wyoming, USA, Regovant LLC is a fully verifiable FDA-compliant U.S. Agent entity supporting global exporters entering the U.S. market.