Meet the People Behind Your FDA Compliance
Our Miami-based team supports domestic and international companies with FDA registrations, U.S. Agent service, FSVP, cosmetics, medical devices, labeling, import compliance and ongoing regulatory maintenance. Clients work with real people who coordinate filings, answer compliance questions and keep regulatory projects organized from intake through completion.
Talk to a specialist. Tell us what you make, import or sell in the United States. We confirm what FDA requires and send a clear scope and quote.
Contact Our TeamThe Team Supporting Your U.S. FDA Compliance
The people who coordinate regulatory submissions, client communication, documentation, billing and ongoing compliance support across our practice.
Hector Matos
Founder and Principal of FDA Registration Assistance. Hector holds a BA in Political Science with a minor in Business from Seton Hall University and concentrates on FDA regulatory policy, food compliance, import matters and medical device regulatory support.
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Isabela Olaya
Isabela works with domestic and foreign businesses on FDA registration, biennial renewals, Prior Notice, U.S. market-entry questions and import-compliance coordination while keeping clients informed throughout the process.
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Michael Alvarez
Michael works directly with domestic and foreign businesses, guiding clients through FDA registration, renewals, Prior Notice, U.S. Agent representation and related compliance coordination while keeping projects moving efficiently.
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Eric Cantreli
Eric helps clients navigate FDA food facility registration, renewals, U.S. Agent representation, Prior Notice and import-compliance questions with an emphasis on clear communication and responsive follow-through.
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Deanne Tanteras
Deanne supports clients and the regulatory team with intake, documentation, scheduling and filing coordination, keeping FDA registrations, renewals and supporting records organized from first contact through completion.
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Vanessa Gonzalez
Vanessa manages accounting and billing for FDA Registration Assistance, keeping invoicing, payments and financial records accurate and organized across client engagements and ongoing renewals.
View full profile of VanessaFDA Compliance Specialists, Not a Law Firm
| Need | Our team | Attorney |
|---|---|---|
| FDA registration, listing and renewals | Yes, we prepare and file | Not usually needed |
| U.S. Agent for foreign facilities | Yes, we serve as agent | Not usually needed |
| Label and claim review | Yes, against FDA rules | For legal opinions or disputes |
| Import detention response documents | Yes, we prepare the evidence | If seizure or court action follows |
| Litigation, criminal matters, contracts | No | Yes |
Many companies searching for an "FDA lawyer" need regulatory filings and documentation rather than legal representation. We handle that work directly and can coordinate with your counsel when a matter needs one.
What Clients Can Expect From Our Team
Direct Specialist Access
Work directly with compliance professionals who explain requirements, answer questions and keep your project moving.
Global Reach, U.S. Focus
We support businesses in 135+ countries while concentrating on U.S. FDA requirements and the practical steps to enter and stay in the U.S. market.
Responsive Turnaround
Clear timelines, responsive communication and efficient execution without sacrificing accuracy.
Compliance Across Industries
Food, FSVP, cosmetics, medical devices, drugs, labeling, U.S. Agent, import and detention needs.Ongoing Support
FDA compliance continues after the first filing. We manage renewals, updates, product expansion and regulatory changes over time.
BBB Accredited
An additional independent trust signal for clients evaluating a long-term U.S. regulatory compliance partner.
Work Directly With Our Team
Need help with an FDA registration, FSVP, U.S. Agent, cosmetics, medical device, labeling or import-compliance project? Tell us about your product and a specialist will confirm what FDA requires and send a clear quote.
- A real specialist reviews every inquiry.
- Requirements confirmed before any paid work begins.
- Our fees and any FDA fees identified separately.
Contact our specialists, email info@fdaregistrationassistance.com, or call +1 (928) 275-8333. All services · About us · Registration pricing.
Contact Our TeamFDA Registration Assistance is a private consulting firm, not FDA or any government agency. FDA registration is not FDA approval, clearance or certification.
Frequently Asked Questions — Our Team
Who is on the FDA Registration Assistance team?
Our team is led by founder and principal Hector Matos, Senior Regulatory Compliance Specialist, with client support specialists Isabela Olaya, Michael Alvarez and Eric Cantreli, administrative assistant Deanne Tanteras and accountant Vanessa Gonzalez. Together they handle intake, filings, renewals, U.S. Agent service, import coordination and billing.
Who leads FDA Registration Assistance?
Hector Matos, founder and principal. Hector holds a BA in Political Science with a minor in Business from Seton Hall University and concentrates on FDA regulatory policy, food compliance, import matters and medical device regulatory support, with 15+ years of FDA compliance experience.
Are you FDA lawyers or a law firm?
No. FDA Registration Assistance is an independent regulatory consulting firm, not a law firm, and our team members are not attorneys and do not give legal advice. We handle the regulatory work itself: FDA registrations and listings, U.S. Agent service, FSVP, Prior Notice, label reviews and documentation for import holds. If your matter involves litigation, a criminal investigation, a seizure or injunction, or a question of legal liability, retain an attorney; we can work alongside your counsel on the regulatory filings.
Do I need an FDA lawyer for an import detention or refusal?
Not always. Many detentions come from missing or inaccurate registration, Prior Notice, labeling or product information. FDA gives the owner or consignee a notice and an opportunity to introduce testimony, orally or in writing, on whether the product is admissible (21 CFR 1.94), and that response is usually documentation. We help prepare it and fix the cause. Consider an attorney when the case moves to seizure, court action or a legal dispute. See import refusal and detention help.
Do I need a lawyer for cosmetic FDA compliance under MoCRA?
Usually not for the core requirements. MoCRA facility registration, product listing, U.S. Agent designation for foreign facilities, label review and adverse event procedures are regulatory tasks our team handles. Legal counsel makes sense for disputes, contracts, product liability or enforcement litigation. See our cosmetic regulatory services.
Where is FDA Registration Assistance located?
Our headquarters is in Miami, Florida. We work with companies across Miami-Dade, including Doral, Hialeah, Coral Gables, Brickell, Miami Lakes and the Miami Free Zone, and with businesses across the United States and in 135+ countries remotely. See FDA registration in Miami.
What can your team help with?
Food facility registration and renewals, U.S. Agent service for food, drug, device and cosmetic facilities, FSVP, Prior Notice, label and ingredient review, drug establishment registration and NDC listing, medical device registration and listing, MoCRA cosmetic registration and listing, import detentions and import alerts. See all FDA services.
Is FDA Registration Assistance affiliated with FDA?
No. We are an independent private company and are not affiliated with or endorsed by the U.S. Food and Drug Administration. We prepare and file on our clients' behalf through FDA's systems. FDA registration is not FDA approval, and we never describe it that way.
How long has FDA Registration Assistance been in business?
Since 2013. Over that time the team has supported 1,000+ companies in 135+ countries, with long-term clients who use us for renewals, listing updates and new products each year.
Is FDA Registration Assistance BBB accredited?
Yes. FDA Registration Assistance is a BBB Accredited Business, which gives companies evaluating a long-term U.S. regulatory compliance partner an independent trust signal.
How do I contact the team?
Use the form at the bottom of this page, email info@fdaregistrationassistance.com or call +1 (928) 275-8333. Tell us your product, where it is made and what you need, and a specialist will reply with the requirements and a clear quote.
Contact the FDA Registration Assistance Team
Tell us what your company makes, sells, or distributes, where each product is manufactured or packed, your U.S. importer or buyer arrangement, label readiness, and target shipment date.
Submitting this inquiry does not purchase a service or authorize paid work. Our team can discuss the scope and required materials before you commission assistance. Fields marked with an asterisk are required.