Food, Supplements, Cosmetics & Regulated Products

FDA Registration Assistance provides professional FDA consulting and regulatory compliance services to businesses in Colón, Panama, as well as exporters worldwide shipping FDA-regulated products to the United States.

Colón is one of Latin America’s most important logistics and export centers, anchored by the Port of Colón and the Colón Free Zone — the largest free trade zone in the Western Hemisphere. The region supports major food exporters, seafood processors, beverage manufacturers, supplement distributors, cosmetic brands, pharmaceutical operations, and international trading companies moving goods into the U.S. market. Any FDA-regulated product exported from Colón to the United States must fully comply with U.S. FDA regulations prior to shipment to avoid costly delays, refusals, or enforcement actions.

FDA Services Available for Colón-Based Businesses

FDA Registration Assistance supports manufacturers, processors, exporters, distributors, and trading companies across Colón in all FDA-regulated industries.

We provide FDA Food Facility Registration for foreign facilities that manufacture, process, pack, or hold food products for export to the U.S.

We offer full Foreign Supplier Verification Program (FSVP) compliance and serve as your official FSVP Agent for U.S. importers sourcing products from Panama.

Our regulatory experts conduct detailed FDA Label Reviews for food, dietary supplements, cosmetics, drugs, and medical devices to ensure compliance before shipment.

We assist cosmetic companies with MoCRA compliance, including cosmetic facility registration and product listing.

We also support:
• FDA Drug Establishment Registration
• FDA Medical Device Establishment Registration
• Required FDA product listings

Why Colón Exporters Choose FDA Registration Assistance

Colón-based exporters work with FDA Registration Assistance because we specialize in foreign facility FDA compliance and U.S. import regulations.

As a U.S.-based FDA consulting firm serving clients across Latin America, Asia, the Middle East, Africa, and more than 75 countries worldwide, we provide clear, structured, step-by-step support — from facility evaluation through registrations, listings, U.S. Agent services, and ongoing compliance monitoring.

Our goal is to make FDA compliance simple, predictable, and stress-free so your exports move smoothly into the United States.

Exporting From Colón to the United States: FDA Compliance Requirements

Most FDA-regulated exports from Panama typically require:

FDA facility registration
U.S. Agent appointment
FDA Prior Notice for food shipments
Compliant labeling and safety standards
Active yearly renewals

Failure to comply can result in shipment holds, refusal of entry, import alerts, recalls, and financial losses.

How the FDA Compliance Process Works

With FDA Registration Assistance:

You submit facility and product details
We determine all applicable FDA requirements
We complete and submit registrations and listings
You receive confirmation and continuous compliance support