Polsinelli welcomes highly experienced life science regulatory strategist and attorney Melissa Gilmore as a shareholder and leader of the firm’s FDA practice. A leading authority on Compounding Pharmacy Regulation and the recently passed Compounding Quality Act, Gilmore will focus her practice on implementation of the law issues as well as her long-standing expertise in the regulation of and financial transactions with medical device, dietary supplement, cosmetics, drug and food companies.
“Melissa is a highly regarded legal strategist who uses her broad FDA experience to provide clients a unique, value-added approach when it comes to helping our clients structure and implement the regulatory aspects of their business plans,” said Polsinelli Life Sciences Chair Kevin R. Sweeney. “We are extremely pleased to have her on our team. Melissa’s industry relationships and FDA agency contacts greatly enhance our ability to provide clients with the best possible solutions for their complex business needs.”
Collaborating with her strong contacts network at the FDA, Gilmore provides life sciences companies with strategic, comprehensive, regulatory guidance to achieve the most effective and efficient results. She also performs preventive liability consulting and conducts due diligence audits for companies interested in financial transactions with regulated health sciences businesses.
“Most assuredly, I am excited to have the opportunity to team up with some of the country’s brightest life sciences and healthcare legal minds,” Gilmore said. “But I was particularly attracted to Polsinelli’s well-deserved national reputation for a sophisticated, business-minded approach to practicing law. Polsinelli is a firm committed to understanding business and providing the legal savvy to ensure clients have practical legal guidance toward making better business decisions.”
The addition of Gilmore occurs during an exciting period of overall growth for Polsinelli, which has seen its national footprint expand to eleven states and 18 cities. The Washington, D.C. office, which opened in 2005, was recently ranked (Tier 1) by US News-Best Lawyers: Best Law Firms, for government relations in the District of Columbia.
Polsinelli also was recently recognized as the fastest-growing law firm in America in 2008 -2012 by The American Lawyer. In 2013, the firm moved up to the 69th position from 78th in The National Law Journal’s ranking of the largest U.S. based law firms. The American Lawyer Magazine featured Polsinelli in its June 2013 issue.
Gilmore earned her law degree, cum laude, from Georgetown University Law Center in 1996 after earning an A.B. degree, cum laude, from Duke University along with on MBA certificates from the Fuqua School of Business 1991. She is a member of the American Bar Association, the District of Columbia Bar Association, the Women’s Bar Association and is co-chair of the Membership Committee of the Women’s Bar Association of the District of Columbia.
Gilmore also is an active member of the life sciences community and frequently speaks and writes about developing FDA and other federal health regulatory issues. She publishes a weekly Life Sciences NewsBrief for both a national and international audience.
Gilmore is an excellent source for reporters working on stories about:
• Compounding Pharmacy issues & the CQA
• Liability protections in health care, FDA products and life sciences
• Financial transactions due diligence for FDA-regulated companies
• Development, approval, manufacture, marketing and advertising of FDA regulated products
• Adverse event mitigation
For more information contact Public Relations Manager Heather McMichael, 816-223-8780, email@example.com
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