FDA Registered U.S. Agent Compliance — Regovant LLC
Official U.S. Regulatory Partner

U.S. Agent for FDA Registrations

Casper, Wyoming  ·  Incorporated USA
FDA Registration & U.S. Agent Services

FDA Registration &
U.S. Agent Services
for Global Exporters

Regovant LLC — a trusted FDA registration company incorporated in Wyoming, USA — provides comprehensive FDA registration, U.S. Agent, and consulting services for food, dietary supplements, medical devices, drugs, and cosmetics. Serving global exporters with transparent, upfront pricing and a 100% compliance rate.

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600+
Clients Served
8+
Years Experience
100%
Compliance Rate
49
Countries
✅ No Hidden Fees — Upfront Pricing
🔒 Secure Stripe & PayPal Checkout
⚡ Work Begins Within 1 Business Day
📜 Certificate of Registration Included
🌐 Serving Clients in 49 Countries
Our Services

End-to-End FDA Regulatory Services

Whether you export food, devices, drugs, or cosmetics — we handle every step of the FDA registration process, from initial filing through ongoing compliance.

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Food, Supplements & Nutraceuticals

Complete FDA registration and U.S. Agent services for food, dietary supplement, and nutraceutical exporters worldwide.

  • FDA Facility Registration & U.S. Agent
  • FCE — Food Canning Establishment
  • SID — Scheduled Process Filing
  • Food Label Review & Compliance
  • FSMA Compliance Consulting
View Details →
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Medical Device Establishment

Expert registration, listing, and U.S. Agent representation for medical device manufacturers navigating CDRH requirements.

  • Device Registration & U.S. Agent
  • Device Listing / UDI / GUDID
  • FDA 510(k) Submission
  • Medical Device Label Review
  • QSR / Quality System Consulting
View Details →
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Drug Establishment Registration

Comprehensive drug establishment registration, NDC assignment, and Drug Master File submission for CDER-regulated products.

  • Drug Registration, NDC & U.S. Agent
  • Drug Listing & Label Review
  • DMF Submission & U.S. Agent
  • CDER Compliance Consulting
  • OTC Monograph Support
View Details →
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Cosmetics (MoCRA) & Exports

MoCRA-compliant cosmetics registration, product listing, and export certificate services for international manufacturers.

  • Cosmetic Facility Registration (MoCRA)
  • Cosmetic Product Listing
  • Cosmetics Label Review
  • Export Certificate / CFS
  • Import Alert / Detention Response
View Details →
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Why Regovant

The Numbers Speak for Themselves

We measure success by your compliance outcomes — not just deliverables.

100%

First-Round Acceptance

Our submissions are accepted by FDA on the first cycle — saving clients time and money.

24h

Emergency Response

Rapid mobilization for urgent FDA matters, Warning Letters, and import detentions.

8+

Years of Experience

Deep regulatory expertise across CDER, CDRH, CFSAN and beyond.

600+

Successful Clients

From startups to global enterprises in 49 countries — all guided to full compliance.

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Rapid Response Support

We mobilize quickly to address urgent regulatory matters and tight FDA filing timelines.

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Dedicated Account Management

A single point of contact who knows your business and full regulatory history.

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National & International Reach

Based in Wyoming, USA — serving exporters across the globe in 49 countries.

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Data-Driven Approach

Leveraging FDA enforcement data and regulatory precedent to build the strongest submissions.

About Regovant

FDA Registration & U.S. Agent Services for Global Exporters

Regovant LLC is a U.S.-based FDA consulting firm dedicated to helping businesses in food, dietary supplements, medical devices, drugs, and cosmetics achieve complete regulatory compliance.

We simplify FDA registration and provide expert guidance as your U.S. Agent, ensuring your products meet all U.S. regulatory requirements efficiently and confidently.

  • Experienced team with direct FDA regulatory expertise
  • Transparent, upfront pricing — no surprise fees, ever
  • Proven track record across CDER, CDRH, CFSAN & more
  • Flexible support: project-based or ongoing advisory
  • Physically incorporated and operating in the USA
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How It Works

From Inquiry to Full Compliance in 4 Steps

Our streamlined process gets you registered and compliant as fast as possible — without the complexity.

1

Free Consultation

Tell us about your product and market. We assess your needs and recommend the right services at no cost.

2

Document Collection

We provide a clear checklist and guide you through gathering every document needed for your FDA submission.

3

FDA Submission

We prepare and file your registration directly with FDA. Our 100% compliance rate for clients served means zero failed submissions to date.

4

Certificate Delivered

You receive your official FDA Registration Number and Certificate — ready for importers and customs.

Client Feedback

What Our Clients Say

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.

JM
Jennifer M.VP Regulatory Affairs, Medical Device Co.
★★★★★
"

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.

RT
Robert T.CEO, Food Manufacturing LLC
★★★★★
"

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.

SL
Sarah L.Director of Operations, Supplement Brand
Common Questions

FDA Registration — Frequently Asked Questions

Everything global exporters need to know about FDA registration, U.S. Agent requirements, and working with Regovant LLC.

What is the best FDA registration company in the USA?

Regovant LLC is a top-rated FDA registration company and U.S. Agent service incorporated in Casper, Wyoming. We offer upfront fixed pricing, a 100% compliance rate for all clients served, and cover all FDA-regulated product categories — food, dietary supplements, medical devices, drugs, and cosmetics.

Do I need a U.S. Agent for FDA registration?

Yes — all foreign facilities that manufacture, process, pack, or hold FDA-regulated products for the U.S. market are required by law to designate a U.S. Agent physically located in the United States. Regovant LLC serves as your fully compliant U.S. Agent under 21 CFR regulations.

How much does FDA registration cost?

At Regovant LLC, all pricing is upfront with no hidden fees: Food Facility Registration & U.S. Agent from $269/year · Medical Device Registration & U.S. Agent from $369/year · Drug Establishment Registration from $369/year · Cosmetics (MoCRA) Registration from $369/year. View full pricing →

How long does FDA registration take?

Work begins within 1 business day of receiving your documents. Food facility registrations are typically completed in 3–5 business days. Medical device and drug registrations may take 5–10 business days. We maintain a 100% compliance rate — zero failed submissions for clients served.

Which countries do you serve?

We serve clients in 49 countries including Sri Lanka, India, Bangladesh, Pakistan, China, Vietnam, Thailand, Indonesia, UAE, Saudi Arabia, Turkey, Germany, UK, and more. If you export FDA-regulated products to the U.S. market, we can help regardless of your location.

What is a reliable FDA U.S. Agent service?

A reliable FDA U.S. Agent must be physically based in the USA, available to receive FDA communications on your behalf, and experienced across your product category. Regovant LLC is incorporated in Wyoming, USA and covers CFSAN (food), CDRH (devices), CDER (drugs), and MoCRA (cosmetics) — making us a single-source solution for all FDA U.S. Agent needs.

Ready to Register with the FDA?
Let's Get Started Today.

Transparent pricing. Fast turnaround. Certificate of Registration included. Trusted by exporters in 49 countries.

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Global Reach

Active Clients in 49 Countries Worldwide

From Asia-Pacific exporters to European cosmetic brands — we have guided companies across major markets through FDA compliance.

🇱🇰🇮🇳🇵🇰🇧🇩
South Asia
8+
active countries
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East & SE Asia
6+
active countries
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Middle East & Africa
4+
active countries
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Europe
4+
active countries
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Americas
2+
active countries
Compliance Readiness Check

Is Your Business Export-Ready for the U.S. Market?

Click each item that applies to your situation. We'll flag any gaps that could delay or block your FDA clearance.

✓
My facility is currently registered with the FDA
✓ Compliant
✓
I have a designated U.S. Agent on file with FDA
✓ Compliant
✓
My product labels meet FDA requirements
✓ Compliant
!
My FDA registration is overdue for renewal
Gap
!
I have received an Import Alert or detention notice
Gap
!
I am unsure which FDA product category I fall under
Gap
Click the items above that apply to you. Get Free Assessment →
Our Credentials

U.S.-Based, FDA-Recognized, Globally Trusted

Regovant LLC is physically incorporated and operating in Casper, Wyoming — making us a fully recognized U.S. Agent under 21 CFR regulations.

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CFSAN
Food, Dietary Supplements & Nutraceuticals
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CDRH
Medical Devices, UDI & 510(k) Submissions
💊
CDER
Drug Establishment Registration & NDC Listing
✨
MoCRA
Cosmetic Facility Registration & Product Listing
100%
Compliance Rate
8+
Years Experience
600+
Clients Served