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
Domaines D’Expertise





  • 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).






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



District of Columbia
Profile Image
Get In Touch
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.

Unsere Kunden verlassen sich auf unsere erstklassige Beratung, vor allem im Hinblick auf komplexe Transaktionen und High-Stakes-Prozesse. Spezialisiert auf Angelegenheiten der Finanz-, Life-Sciences-, Private-Equity-, Immobilien-und Technologie-Branchen, verwenden wir einen kooperativen und interdisziplinären Ansatz, um Fragen unserer Kunden auch in extremen Spezialsituationen einer Lösung zuzuführen. Sie wollen mehr erfahren? Kontaktieren Sie uns gerne.

Nos équipes interviennent aux côtés de nos clients, industriels, fonds d’investissement, startups, institutions financières et dirigeants, dans le cadre de transactions et de contentieux complexes, et apportent des conseils de tout premier plan dans les secteurs financiers, des Sciences de la Vie, du Private Equity, de l’immobilier et des technologies. Nous traitons les dossiers juridiques de manière intègre, ingénieuse, souple et audacieuse pour répondre efficacement aux enjeux propres à chacun de nos clients, quels que soient la taille de l’opération et le secteur d’activité. Pour en savoir plus, contactez-nous.


Search Other Lawyers
Recherche par Pratique