Seth Gitner is an associate in Goodwin’s Technology and Life Sciences groups and a member of the firm’s FDA regulatory practice. He conducts regulatory due diligence on FDA-regulated companies in initial and follow-on public offerings, mergers and acquisitions, and private equity investments. He also counsels pharmaceutical, biologic and medical device companies on FDA regulatory compliance matters, including both pre- and post-market regulatory compliance requirements across the product life cycle from early-stage development and interactions with FDA to product advertising and promotion.
Areas of Practice
TÄTIGKEITSFELDER
Domaines D’Expertise
业务范围

Experience

ERFAHRUNG

EXPÉRIENCE

工作经历

  • Counsel clients on Emergency Use Authorization vaccine distribution matters
  • Counsel clients regarding FDA regulatory matters to facilitate bringing new products and processes into the marketplace; including navigating FDA regulatory interactions and making determinations regarding whether products are cleared, subject to an exemption, or require a formal filing with the agency
  • Advise on regulatory disclosures and review of drug and device company therapeutics and technologies during initial public offerings
  • Counsel on the regulatory terms of a range of commercial contracts, including quality agreements
  • Advise drug developers on regulatory compliance requirements related to clinical and quality issues that arise during the product development stage
  • Work closely with scientists and outside laboratories in conducting safety and technical suitability analyses necessary to get products onto the market
Professional Experience

Mr. Gitner has been providing counsel to FDA regulated companies for the past two years, focusing on establishing the suitable FDA regulatory status of various products and procedures, with clients ranging from large corporations to trade organizations.

Before joining Goodwin, Mr. Gitner was an associate with Keller and Heckman LLP’s FDA regulatory practice. While in law school, Mr. Gitner was a Lead Civil Intern for the D.C. Superior Court where he conducted legal research and edited and reviewed motions and memoranda. In addition, he was a member of Georgetown’s Environmental Law Review, served as the co-president of Georgetown’s Food Law Society, and was a board member of the National Food Law Student Network.

After receiving his bachelor’s degree, Mr. Gitner was a legal assistant for a litigation firm where he researched and compiled discovery documents for the attorneys in preparation for depositions and trials. Prior to his tenure at the litigation firm, Mr. Gitner served as an intern on Capitol Hill and in the government relation’s arm of a government agency.

Professional Activities

Mr. Gitner is a member of the Food and Drug Law Institute as well as the Virginia Biotechnology Association (Virginia Bio).

Credentials

WERDEGANG

RÉFÉRENCES

专业资格

Education

J.D., 2018
Georgetown University Law Center
B.A., Philosophy, 2010
University of Colorado at Boulder

Admissions

Bar

District of Columbia
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Our clients rely on us for world-class advisory services, counsel on complex transactional work and high-stakes litigation. Specializing in matters involving the financial, life sciences, private equity, real estate, and technology industries, we use a collaborative, cross-disciplinary approach to resolve our clients’ most challenging issues. To find out more, please contact us.

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