Food, Supplements, Cosmetics & Regulated Products

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

Asunción is Paraguay’s primary commercial, manufacturing, and river-port logistics center — supporting food processors, agricultural exporters, meat and grain producers, beverage manufacturers, dietary supplement companies, cosmetic brands, pharmaceutical operations, and international trading firms serving the U.S. market. Any FDA-regulated product exported from Asunción to the United States must fully comply with U.S. FDA regulations prior to shipment to avoid delays, refusals, or enforcement actions.

FDA Services Available for Asunción-Based Businesses

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

We provide FDA Food Facility Registration for foreign facilities that manufacture, process, pack, or hold food products exported to the United States.

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

Our regulatory specialists conduct professional 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 Asunción Exporters Choose FDA Registration Assistance

Asunción-based exporters partner with FDA Registration Assistance because we specialize in foreign facility FDA compliance and international trade regulations for the U.S. market.

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 structured, step-by-step guidance — from facility review through registrations, listings, U.S. Agent services, and ongoing compliance monitoring.

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

Exporting From Asunción to the United States: FDA Compliance Requirements

Most FDA-regulated exports from Paraguay 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 may result in shipment detention, refusal of entry, import alerts, recalls, and financial losses.

How the FDA Compliance Process Works

With FDA Registration Assistance:

You provide facility and product information
We identify all applicable FDA requirements
We prepare and submit registrations and listings
You receive confirmation and ongoing compliance support