FDA Regulatory

test tubes
Advising many of the world’s leading pharmaceutical, biotechnology, medical device, food, cosmetic and other FDA-regulated life sciences companies, Ropes & Gray guides clients through the entire product life cycle.

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“The regulatory group possesses particularly deep experience in the pharmaceutical and medical device realms, a factor that is further enhanced by the firm’s commitment to utilize, when necessary, the transactional and litigation attorneys who specialize in related life sciences industries.” 

LMG Life Sciences
“They know the industry, they know the players, and they understand the interaction between manufacturing, IP and regulatory issues.” Client and Market Sources, Chambers USA

Overview

A clear understanding of FDA regulatory requirements is essential to the success of a life sciences company. Our Washington, D.C.-based FDA regulatory team includes seasoned lawyers knowledgeable in all areas of FDA regulation. The team’s varied backgrounds bring a breadth of perspectives to the practice which includes attorneys who have worked at the FDA, as in-house counsel at life sciences companies and as key policy advisors in Congress.

Our clients include many of the world’s leading pharmaceutical and biologics companies, medical device manufacturers and cosmetics, food and dietary supplement companies and distributors. We offer comprehensive services, including:

As part of our multidisciplinary life sciences group, our FDA regulatory team has a broad view of the commercial and regulatory forces affecting life sciences companies. In addition to traditional regulatory counseling and administrative litigation, we advise clients on corporate and transactional matters, government enforcement investigations, compliance program design and implementation, and FDA-related intellectual property analyses and litigation.

We also provide counseling to clients regarding other related government agencies, including the Federal Trade Commission (FTC), Consumer Product Safety Commission (CSPC) and the U.S. Department of Agriculture (USDA). Our advertising practice also includes representation of clients subject to challenges brought before the National Advertising Division of the Better Business Bureau (NAD). For more information about our services, please contact one of our FDA attorneys.

Industries Served

Our FDA attorneys have extensive knowledge and experience across various industries and segments within the life sciences industry. Our practice provides regulatory services for the following areas: