Regovant LLC

Regovant LLC is a U.S.-based company that offers FDA regulatory services to help international manufacturers and exporters ensure their products meet FDA standards for entry into the United States. We serve as a designated U.S. Agent and deliver comprehensive support for FDA registration, communication, and regulatory compliance. Our primary services encompass FDA Food Facility Registration, U.S. Agent services, Medical Device Establishment Registration and Listing, Drug Establishment Registration, compliance with Cosmetic MoCRA, label review, and regulatory consulting. Additionally, we assist with export/import compliance, including filing FDA Prior Notice for food shipments and establishing the Foreign Supplier Verification Program (FSVP) for U.S. importers in accordance with FSMA regulations. Our offerings also include FCE registration, SID filing, UDI compliance, 510(k) assistance, DMF submissions, and Certificates of Free Sale, tailored to the specific product categories. With over 600 clients across 49 countries, Regovant is recognized for its rapid service, transparent pricing, and dependable compliance support. We initiate our services within one business day and provide structured, customized guidance based on each product category. Located in Wyoming, USA, Regovant LLC is a fully legitimate FDA-compliant U.S. Agent organization that aids global exporters in entering the U.S. market.