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US Agent and Imports

EAS Consulting Group serves as US Agent for importers of FDA regulated products into the United States. From submissions assistance, to facility registrations, to detained products, our team of qualified experts work with regulatory authorities to solve problems, ensure compliance and file required documentation accurately and in a timely manner. By acting as in intermediary between FDA and the foreign firm, EAS helps clients import their compliant products into the U.S. marketplace as quickly as possible.

Choose EAS for:

Establishment Registrations

Drug Submissions (IND, DMF, ANDA, Amendments)

Medical Device Applications and Correspondence (510(k), 513(g) PMA, IDEs)

Establishment Registration & Process Filing for Acidified and Low-Acid Canned Foods (LACF)

Food Facility Registrations

US Agent Services for Foreign Color Manufacturers Testing and Approval

Preparation for FDA Inspections of Foreign Facilities

Corrective Action Plans

Assistance with Detained Products

Registration of Importers and DUNS Numbers

National Drug Code Listings

Tobacco PMTA Submissions

Food Submissions (GRAS, FCN, Food Additive Petitions

New Dietary Ingredient Submissions (NDI)

USDA AHPHIS Animal & Plant Health Import Permits

Foreign firms face many import challenges from lack of prior notice, inaccurate labeling, and claims, LACF registration challenges, supplier qualifications under the Food Safety Modernization Act (FSMA) and more. Trust EAS to ensure your firm receives the detailed assistance required.

Additionally, EAS helps foreign firms exporting products to the US prepare for FDA foreign inspections by conducting “Mock-FDA” inspections before FDA arrives. EAS can also help foreign food firms that have already been inspected by FDA and found to have a violation and to make the needed corrections to bring themselves into full compliance with FDA requirements.

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