Presented by Bryan Coleman 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 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 and facility registrations, product listings as well as submissions such as Foreign Color Manufacturers Testing and Approval through FDA, drug submissions such as IND, DMF, ANDA and their amendments and annual updates, and medical device applications such as 510(k), 513(g), PMA and IDE.
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.
This webinar is presented by EAS Senior Director for Pharmaceutical and Medical Device Consulting Services, Bryan J. Coleman and Regulatory Specialist, Victoria Pankovich have covered important basic requirements of the US Agent role as well as opportunities to enhance your understanding of FDA oversight of foreign facilities.
About the Presenters
Bryan Coleman, Senior Director Pharma and Devices
EAS Senior Director for Pharmaceuticals and Medical Devices, Bryan Coleman facilitates compliance for pharmaceuticals, OTC, medical device and combination products. He spent five years at FDA, including roles as a chemist, and then a consumer safety officer (CSO/Investigator), where he performed a wide variety of field inspection work in finished pharmaceutical and API (Rx/OTC/Veterinary Medicines) for GMPs and PAI, BIMO/GCP, medicated animal feed operations, medical device, cosmetics, food and dietary supplement manufacturing, packaging/labeling and distribution facilities. Additionally, he conducted product complaint and recall surveillance activities. While at FDA, Bryan served on FDA’s Foreign Inspection cadre for drug inspection work. He was the lead on FDA inspection management programs, supplier due diligence and corporate audit conformance. Immediately prior to joining EAS, he was Senior Manager of Quality Programs and Projects at Altria Client Services where he was the lead for the internal quality and supplier audits program, quality system development and provided clinical study oversight. Prior to Altria, he spent nearly 14 years as the Director of Quality and Compliance for Research and Development at Pfizer Consumer Healthcare, where he oversaw all aspects of quality for multiple sites engaged in development, clinical supply production/release, clinical study oversight, CAPAs and regulatory conformance.
Bryan has practical industry experience with pharmaceuticals, medical devices, dietary supplements and tobacco/ENDS products/processes in the areas of development, improvement, and implementation of sound Quality Systems that are efficient, sustainable, and compliant with FDA regulations. He recently retired from a 30-year career in the Virginia Army National Guard, attaining the rank of Colonel.