Ted Lis

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.