Elizabeth Oestreich

Quality & Compliance Practice

BACKGROUND

FOCUS AREAS

Diverse background provides critical expertise within legal, public policy, regulatory advocacy, and non-profit sectors to enable strategic guidance on FDA regulatory compliance and advisory services support for life science transactions.

Drug GMP
Family Smoking Prevention and Tobacco Control Act
FDA regulation of Cannabis and Cannabis-derived products
Due Diligence

Liz brings more than ten years of regulatory experience and diverse knowledge of legal and public policy matters to her position at ELIQUENT Life Sciences.. Liz provides strategic guidance on premarket and postmarket issues, specifically related to regulatory compliance. She works with pharmaceutical and medical device clients to prepare for FDA inspection and to address and remediate compliance matters. She advises clients on FDA communication, including 483 and warning letter responses, and offers guidance on agency expectations and regulatory policy.

Liz also leads the Advisory Services practice area, working with life science investors and industry to evaluate the potential regulatory risks during the due diligence stage of transactions.

Liz has particular expertise in two of the FDA’s newest regulated product categories, tobacco and cannabis-derived products. Liz advises clients navigating the regulatory landscape for tobacco products and assists with content and format of applications, interpretation of FDA regulation, engagement with the FDA and stakeholders, and policy development. Liz also offers strategic guidance and risk-based strategies to stakeholders in the cannabis industry, including CBD manufacturers and distributors, as the regulatory landscape evolves.

Prior to joining Greenleaf Health, Liz served as Director of Educational Programming for the Food and Drug Law Institute (FDLI) in Washington, D.C. While at the Food and Drug Law Institute (FDLI), she gained extensive experience in all FDA-regulated product areas. Liz’s role included regularly corresponding with FDA officials, as well as creating and supervising the development of curricula for an array of educational programs. She led FDLI’s committees responsible for monitoring regulatory developments in the tobacco and pharmaceutical industries and served as Editor-in-Chief of the Food and Drug Law Journal. Before earning her law degree, Liz worked as a government relations professional for the Society of Chemical Manufacturers and Affiliates (SOCMA), where she directed a grassroots network of more than 100 member companies.