Extended U.S. FDA Compliance Consulting
Regulatory support for domestic and foreign manufacturers, exporters, importers and distributors navigating U.S. FDA requirements for food, dietary supplements, cosmetics, pharmaceuticals and medical devices.
Serving Manufacturers & Exporters Worldwide
U.S. FDA compliance requirements can vary significantly according to product category, establishment activity, importer structure and country of manufacture. Our consulting services help companies identify and address the requirements applicable to their U.S. operations.
Asia
FDA establishment registration, Initial Importer support, product listing, labeling review, food facility registration, FSVP guidance, regulatory documentation and pre-inspection preparation for manufacturers and exporters throughout Asia.
Africa
Food facility registration, FSMA and FSVP compliance, dietary supplement labeling, U.S. Agent support, import documentation, detention assistance and regulatory consulting for African manufacturers exporting FDA-regulated products.
Latin America
FDA registration and listing, medical device compliance, food-import requirements, FSVP support, labeling review, U.S. Agent services and regulatory consulting for manufacturers and exporters throughout Latin America.
Europe
Regulatory strategies for European companies adapting existing compliance programs to U.S. FDA requirements, including medical devices, pharmaceuticals, food, cosmetics and dietary supplements.
Extended FDA Compliance Capabilities
Support can be tailored to the product, establishment and stage of U.S. market entry.
Preparing to Manufacture, Export or Sell FDA-Regulated Products in the United States?
Explore extended U.S. FDA compliance services designed for domestic businesses and foreign manufacturers, exporters, importers and distributors operating across food, dietary supplements, cosmetics, pharmaceuticals and medical devices.
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