Faegre Drinker today announced that Ted Lis has joined its Washington, D.C., office as counsel with the FDA Regulated Products team of the Government & Regulatory Affairs group. Lis comes to the firm from Sidley Austin LLP.
A deeply experienced lawyer and chemical engineer, Lis works with life sciences manufacturers and other clients to address potential good manufacturing practice (GMP) and quality system regulation issues. Over the course of his career, he has assisted companies in more than a dozen countries that produce active pharmaceutical ingredients, aseptic injectables, biologics, combination products, ophthalmics, oral solid doses, medical devices and vaccines.
Lis partners with companies to manage their interactions with regulatory agencies, preparing for 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 inspectors’ requests.
“Ted’s particular skills in helping life sciences companies protect their critical manufacturing and supply chain capabilities is an important addition to our FDA Regulated Products team capabilities,” said David R. Zook, leader of Faegre Drinker’s Government & Regulatory Affairs group. “These issues are important at all times and particularly during a time of global stress on client systems such as now.”
With more than 125 attorneys, consultants and professionals, Faegre Drinker’s Government & Regulatory Affairs group has a deep understanding of how government functions at all levels and across an array of subject-matter and technical areas. Members of the group include former federal, state and local government officials as well as those with significant private-sector experience who represent clients in legislative, regulatory and administrative matters with extraordinary passion and depth of experience in building and operating advocacy and technical collaboratives. The group offers specialized support for mergers and acquisitions, high-stakes litigation, and enforcement matters, and it has on-the-ground presences in Washington, D.C., and multiple state capitals.