Ted Lis
Counsel Global Regulatory
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Overview
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Experience
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Credentials
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Insights and events
Ted Lis entered the practice of law after nearly a decade as a chemical engineer for a major American chemical company and is a senior member of the American Institute of Chemical Engineers. He uses his legal and engineering training to provide in-depth counsel to clients whose manufacturing processes are subject to current Good Manufacturing Practice (cGMP) regulation. Over the course of his career, Ted has assisted clients resolve cGMP issues pertaining to API, aseptic injectables, biologics, combination products, ophthalmic products, oral solid doses, medical devices, vaccines, and other regulated products.
Working with industry and company professionals, Ted applies his broad experience to advise quality and manufacturing managers and senior executives who face critical issues that are the focus of regulators. He assists clients with managing communications with regulatory agencies, preparing for pending site inspections, and training personnel. He also provides on-site support during inspections to assist subject-matter experts in cogently and succinctly presenting information that is relevant to investigators’ requests.
During the COVID-19 public health emergency, Ted has assisted clients in preparing Emergency Use Authorization applications and communicating with FDA for medical devices that include in vitro diagnostic tests, personal protective equipment and ventilators. Ted also has experience in conducting internal investigations involving alleged FDA violations.
In addition to GMP regulation enforcement work, Ted is an experienced litigator. He has represented pharmaceutical companies when deposing plaintiffs, physicians and expert witnesses in support of dispositive motions and Daubert motions to exclude expert testimony.
Credentials
- J.D., Georgetown University Law Center, 2002
- B.S. Chemical Engineering, Drexel University, 1990
- District of Columbia
- Virginia
- U.S. District Court, Eastern District of Virginia
- U.S. Bankruptcy Court, Eastern District of Virginia
- Member, International Organization for Standardization (ISO)
- Member, Parenteral Drug Association (PDA)
- Senior Member, American Institute of Chemical Engineeers (AIChE)