EAS Consulting Group provides U.S. Agent services to international clients in various FDA regulated areas to register the facility or products as needed and acts as a conduit of information between FDA and the foreign firm. By quickly responding to questions and concerns in a timely manner EAS helps clients get their compliant products to 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
EAS Consulting Group serves as the U.S. Agent for foreign color manufacturers who are required by law to submit each batch of color for certification by FDA. EAS submits these colors to FDA for testing and serves as the intermediary between the foreign manufacturer and FDA.
EAS Consulting Group has a team of qualified experts to submit establishment registration and process filing forms on behalf of foreign firms that manufacturer acidified or low acid canned foods for sale in the United States. Click here to learn more about this service.
EAS Consulting Group also assists with products which are being held under FDA detention. Whether the issue is lack of prior notice, inaccurate labeling and claims, LACF registration problems or other issues, our experts in import issues will work with the authorities and your company to solve the issues surrounding your product’s detention.
The Food Safety Modernization Act has changed the role of the food importer and has increased the number of foreign food inspections FDA conducts. EAS is available to help importers understand their new “food safety” responsibilities and can assist them in fulfilling their supplier qualification requirements for each food product they import. Conversely, EAS can help foreign firms exporting food 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.