The Role of Your US Agent

Presented by Victoria Pankovich and Lisa El-Shall

March 18, 2025, 1pm (eastern)

Foreign entities who operate in US FDA regulated industries must have an appointed US agent before doing business and importing products into the US. 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 submissions such as IND, DMF, ANDA 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 submissions prior to FDA submission, preparation for FDA facility inspections (both through mock-inspections and desk-reviews of documentation), any 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

Victoria Pankovich

Manager, Regulatory Services

Reporting to the Senior Director Pharmaceutical & Medical Device Consulting, Victoria Pankovich supports clients through assembling and processing FDA submissions including Drug Master Files, Abbreviated New Drug Applications and New Drug Applications. Serve as the primary US Agent for all required communications with FDA on behalf of clients, including Establishment Inspection coordination with FDA, Drug, Medical Device and Food facilities registration; Drug and Medical Device product listings; Color Certification requests; FDA Inspection Notifications; FOl and FDA Controlled Correspondence requests.

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.

Posted in Drugs, Webinar.