Understanding the Role of Your U.S. Agent

Presented by Lisa El-Shall and Victoria Pankovich

Foreign entities who operate in US FDA regulated industries must have an appointed US agent before doing business and importing products into the United States. US Agents act as an intermediary between the foreign company and FDA, assisting with two-way communication on requirements and questions such as establishment registrations and product listings; submissions such as Foreign Color Manufacturers Testing and Approval through FDA; drug applications and files such as NDA, ANDA, DMF and IND and their required submissions (Annual Reports, Amendments, LoAs); and medical device applications such as 510(k), 513(g), deNovo, etc.

In addition to these basic requirements, regulatory US Agents have expertise in providing additional services to foreign clients such as technical reviews of applications or master files prior to FDA submission, preparation for FDA facility inspections (both through mock-inspections and desk-reviews of documentation), Corrective Action Plans required by FDA and by providing answers to various questions surrounding the complex FDA regulatory requirements.

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About the Presenters

Lisa El-Shall

Senior Director for Pharmaceutical and Device Consulting Services

Lisa El-Shall has a B.S. in Chemistry from the University of North Carolina at Chapel Hill and a M.S. from the University of California, Los Angeles in Biochemistry. She has extensive experience in a Consumer Healthcare organization in both Research and Development and Quality and has held leadership positions in the analytical laboratory and quality. For the past 11 years she led the Research and Development Quality group at Pfizer and GSK with global responsibility for areas including development, clinical supply production/release, clinical study oversight, and business development quality. She has proven ability in establishment, implementation, and maintenance of fit for purpose standards, systems, and Regulatory Inspection compliance.

Victoria Pankovich

Manager, Regulatory Services

Victoria serves as the US Agent contact for all required communications with FDA on behalf of EAS clients, including Establishment Inspection coordination with FDA. This includes Drug, Medical Device, Food, and Cosmetic facility registrations; Drug, Medical Device, and Cosmetic product listings; Batch Color Certification requests; FDA Inspection Notifications; FOI and FDA Controlled Correspondence requests. Support also includes communication with the agency for submissions of Drug Master Files, Abbreviated New Drug Applications and New Drug Applications.

Why Do I Need an FDA US Agent?

Foreign companies planning to manufacture/process and export Drug Products, Medical Devices, Foods, Dietary Supplements, Cosmetics, and the color additives used in Food, Drugs and Cosmetics to be sold in the US are required to enlist the services of a US agent by regulation.

What the Basic Requirements to be an FDA US Agent?

FDA US agents must have a physical address (not a post office box) in the United States. This cannot be in the form of an answering service. The US Agent must be physically located at this address and be available during business hours, with a contact phone number and email address.