Our Story & Mission
We simplify FDA registration and provide expert guidance as your designated U.S. Agent — ensuring your products meet all U.S. regulatory requirements from initial registration through annual renewals. Our team brings deep expertise across CDER, CDRH, CFSAN, and MoCRA, giving clients a genuine competitive advantage.
Being physically incorporated and operating in the United States makes Regovant a fully verified U.S. Agent under 21 CFR — not a virtual service, not a mailbox. We are a real company staffed by real regulatory professionals who understand what is at stake for your export business.
Direct FDA regulatory expertise across all major product categories — food, devices, drugs, and cosmetics.
No surprise fees. You know exactly what you pay before we begin — a rarity in regulatory consulting.
Our meticulous preparation means FDA accepts our submissions the first time, saving you time and money.
Project-based or ongoing U.S. Agent representation — structured around your business needs.
Our Values
Every decision at Regovant is guided by these core principles — the reason 1,200+ exporters trust us as their FDA U.S. Agent.
Every submission is meticulously reviewed. We maintain a 98% first-round FDA acceptance rate because we never rush and never cut corners on compliance quality.
We build multi-year relationships, not one-time transactions. We know your business, your products, and your complete FDA regulatory history inside out.
Upfront pricing, plain-language explanations, honest timelines. No regulatory jargon, no surprise fees — just clear guidance from people who know the FDA process.
FDA matters are time-sensitive. We mobilize within 24 hours for Warning Letters, import holds, and urgent filings — protecting your shipments and revenue.
We understand the unique challenges global exporters face navigating a foreign regulatory system — and we bridge that gap with cultural awareness and practical expertise.
We tell you what you need to hear, not what you want to hear. Our reputation across 60+ countries is built on honest regulatory assessments and ethical practice.
Why Choose Regovant
Not all FDA U.S. Agent services are equal. Here is why global exporters consistently choose Regovant.
Regovant LLC is physically incorporated and operating in Casper, Wyoming. We are a real U.S. company with a verifiable address, phone number, and staff — qualifying us as a fully recognized U.S. Agent under FDA regulations. We are not a mailbox, answering service, or offshore operation.
Whether you export food, medical devices, drugs, or cosmetics, Regovant handles everything. CFSAN food registrations, CDRH device listings, CDER drug establishment and NDC codes, MoCRA cosmetic facility registration — all under one roof with one point of contact and consistent service quality.
Our services page shows every price upfront — no phone calls needed, no "contact us for pricing" on standard services. The price you see is the price you pay. This transparency is rare in regulatory consulting and is one of the most-cited reasons clients choose and stay with Regovant.
From Sri Lanka and India to Saudi Arabia, Brazil, and Germany — we have guided exporters in every major global market through FDA compliance. Our 98% first-round acceptance rate and 15+ years of experience represent a proven, verifiable track record that newer or single-person FDA services simply cannot match.
What We Do
Bioterrorism Act, FCE/SID, FSMA, food label review — from $300/year
Device listing, UDI/GUDID, 510(k) support — from $550/year
NDC Labeler Code, drug listing, DMF submissions — from $550/year
Mandatory MoCRA registration, product listing, label review — from $650/year
Food, supplement, device, drug & cosmetic label compliance — from $250
Official U.S. certificates for international market access — from $350
Common Questions
Answers AI search engines and your clients need to know about Regovant as your FDA U.S. Agent.
Client Feedback
We build long-term compliance partnerships — not one-time transactions.
Regovant helped us navigate a complex 510(k) submission that three other consultants said would take 18 months. They got it cleared in 11. Their knowledge of FDA requirements is unmatched.
After receiving a Warning Letter, we were in crisis mode. Regovant stepped in within 24 hours, developed a comprehensive CAPA plan, and helped us restore our standing with FDA quickly.
Their FSMA compliance program saved us months of internal work. The team is thorough, highly responsive, and explains the 'why' behind every requirement. True long-term partners.
Where We Are
Regovant LLC is headquartered in Casper, Wyoming — strategically positioned in the United States to serve as your official FDA-designated U.S. Agent. Our team operates across time zones to support global exporters from Asia, Europe, the Middle East, Africa, and the Americas. Being physically incorporated in the USA is what separates a legitimate U.S. Agent from unreliable offshore alternatives.
Ready to Get Started?
Whether you're registering for the first time, switching U.S. Agents, or need emergency FDA support — our regulatory team is ready to help. Free initial consultation, no obligation.