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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