FDA COMPLIANCE
& U.S. AGENT SERVICES
U.S. FDA Compliance Services for Regulated Products
Professional regulatory support for foreign manufacturers, exporters, private-label brands, contract manufacturers, distributors, and e-commerce sellers shipping FDA-regulated products to the United States.
Compliance Support Across Major Product Categories
FDA requirements are not identical for every industry. Each category has its own registration systems, labeling rules, quality obligations, importer responsibilities, and enforcement risks.
Food and Beverages
Support for foreign food facilities, exporters, warehouses, private-label brands, and importers handling conventional foods, beverages, ingredients, seafood, canned products, specialty foods, and other products intended for human or animal consumption.
Dietary Supplements
Compliance assistance for finished supplements and dietary ingredients, including establishment registration, product positioning, Supplement Facts, ingredient declarations, claims, warning statements, cGMP documentation, and import readiness.
Cosmetics
Support for cosmetic manufacturers, processors, brand owners, and responsible persons addressing MoCRA facility registration, product listing, U.S. contact information, label review, adverse-event responsibilities, and safety substantiation.
Prescription Drugs
Regulatory support for foreign drug establishments involved in manufacturing, processing, testing, repacking, relabeling, or exporting prescription drug products and active pharmaceutical ingredients to the United States.
Over-the-Counter Drugs
Assistance with establishment registration, drug listing, National Drug Code-related information, OTC monograph positioning, Drug Facts labeling, active and inactive ingredients, warnings, directions, and claims that affect product classification.
Medical Devices
Support for foreign device manufacturers, specification developers, contract manufacturers, sterilizers, relabelers, remanufacturers, exporters, and U.S. initial importers navigating establishment registration, device listing, U.S. Agent, and import compliance.
A Complete FDA Compliance Platform for Foreign Companies
FDA market entry usually involves more than one filing. Our services connect the foreign establishment, regulated product, U.S. parties, labels, listings, quality records, and import documentation.
FDA Establishment Registration
Assistance with initial registration, annual or biennial renewal, updates, establishment activities, product categories, ownership information, facility identifiers, and account-related registration matters.
U.S. Agent Service
Professional U.S. Agent services for foreign food, drug, medical-device, and other regulated establishments requiring a qualified U.S. contact for FDA communications and registration purposes.
Product Listing Support
Assistance with applicable device listings, drug listings, cosmetic product listings, establishment-linked product information, and updates when products, labels, facilities, or responsible parties change.
Labeling and Claims Review
Review of principal display panels, ingredient statements, warnings, directions, intended-use language, Nutrition or Supplement Facts, Drug Facts, device labels, cosmetic declarations, and marketing claims.
FSVP Compliance
Support for foreign food suppliers and U.S. FSVP importers, including hazard analysis, supplier evaluation, verification procedures, corrective actions, record organization, and entry-data coordination.
Medical Device Initial Importer
Assistance for U.S. entities serving as medical-device initial importers, including registration, importer identification, complaint coordination, MDR-related responsibilities, records, and foreign manufacturer communication.
Quality and Compliance Records
Support with SOPs, complaint procedures, supplier files, quality records, food-safety plans, HACCP documents, certificates of analysis, corrective actions, recall planning, and inspection readiness.
Importer of Record Coordination
Guidance on distinguishing the customs Importer of Record from the FDA U.S. Agent, FSVP importer, medical-device initial importer, consignee, distributor, and other parties in the supply chain.
Amazon and E-Commerce Support
Compliance planning for foreign companies shipping FDA-regulated products to Amazon fulfillment centers, third-party logistics providers, distributors, online marketplaces, and direct-to-consumer channels.
FDA Response Assistance
Support when FDA, a customs broker, marketplace, warehouse, customer, or importer requests registration evidence, listing details, label corrections, quality documents, FSVP records, or clarification of responsible parties.
Registration Renewal Services
Annual and biennial renewal support for regulated establishments, including review of company data, ownership, activities, U.S. Agent information, listings, and product categories before the applicable deadline.
Pre-Shipment Compliance Review
A practical review of products, facilities, labels, registrations, listings, U.S. parties, shipping documents, and import arrangements before inventory leaves the country of export.
FDA compliance is a product-specific market-access system.
A registration number alone does not make a product compliant. Foreign companies need a coordinated plan covering the establishment, product classification, labeling, U.S. representatives, listings, quality systems, importer roles, and shipment documentation.
》Discuss Your ProductsA Clear Four-Step Compliance Process
Every project begins with the actual product, establishment activities, labels, U.S. parties, sales channel, and shipment plan.
Collect Information
We review the company, facilities, products, labels, ingredients, intended use, claims, destination, importer arrangements, and expected shipment date.
Identify Requirements
We map registration, listing, U.S. Agent, FSVP, initial importer, labeling, quality, reporting, and import-readiness obligations.
Correct Compliance Gaps
We help organize submissions, revise labels, prepare records, assign responsible parties, and resolve inconsistencies before shipment.
Support U.S. Market Entry
We remain available for updates, renewals, listing questions, importer coordination, document requests, and future product launches.
Prepare Your FDA-Regulated Products for the U.S. Market
Send your product list, facility details, labels, intended use, destination, U.S. importer information, and expected shipment date. A focused compliance review can identify the most urgent requirements before your products leave the country of export.