About The Law Office of Ali Gallagher

Ali Gallagher

As a serial entrepreneur, manufacturer and practicing attorney, Ali Gallagher brings not only decades of legal skills to advocate on behalf of her clients, but she also understands the business perspectives and hurdles they face.   Ali has held C-Suite positions in both publicly traded and privately held companies.  She concentrates her practice in both corporate and regulatory areas, especially with companies developing and marketing FDA regulated products and services.  Her corporate and regulatory knowledge came, in large part, from being the person directly responsible to the shareholders for each area.  

Early in her legal career, Ali worked on Capitol Hill for a ranking member of House of Representatives responsible for an array of healthcare issues.  After launching her first company, she was appointed and served as the industry advisor to the FDA’s medical device panel.  Ali has testified before several US Congressional committees and subcommittees, including the U.S. House of Representative’s Oversight and Investigations Committee on matters affecting small businesses regulated by the FDA.  Ali enjoys advising companies – from formation of a start-up venture with an idea through commercialization, to a successful company wanting to grow or exit.  

Experience

Most recently, advising manufacturers, distributors and importers seeking FDA clearance under the Emergency Use Authorization process to enter the US market, including working with both domestic and foreign manufacturers.

Advised large non-profit organization in the arts on corporate matters.

Practice includes working with a mature technology company helping to position it for expanding its growth and/or sale of the company.  

Managed product recalls for several multinational companies, including filing of medical device reports. 

Advised global company on tariff related matters. 

Assisted companies in responding to post-market regulatory compliance issues, such as website and product claims/labeling, Adverse Event reporting, vendor approval policies, contracting with distributors and vendors and registering and listing products with FDA. 

Advising several clients on FDA pre-market device approval and/or notification obligations, including review of their PMA, 510(k) and 513(g) FDA filings, and the respective corporate obligations for distributors, importers, specification developers, independent contractors of FDA regulated products/services and manufacturers.  

   
Ali graduated from the University of Texas School of Law and is ABD for her PhD in Educational Psychology at UT. She is a former nurse practitioner and holds several medical device patents in the US and globally.  Ali has advised government leaders and heads of companies over the span of her career and doesn’t plan to stop anytime soon helping people to manage their products, services and companies. Her recent community involvement is teaching the Torts section for the Paralegal Program sponsored by the University of Texas School of Law.  She has also participated for the past four years as a mentor for 1L law students at the University of Texas.  Ali sits on the Advisory Board of World Learning, an organization that focusing its work on critical global issues such as poverty, conflict, and inequality.

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She is licensed to practice in Texas and is admitted to the U.S. District Court for the Western District of Texas and the U.S. Court of Federal Claims.