Ashish R. Talati leads Amin Talati & Wasserman’s FDA practice and is one of the industry’s foremost experts on FDA regulatory matters. He has gained an exceptional reputation for his successful results at the cutting edge of FDA and regulatory law, where he has responded nimbly to changes in the regulatory climate and the marketplace, guiding clients through some of our industries’ most complex issues.
Ashish primarily counsels clients on matters of regulatory compliance, helping them anticipate and address regulatory issues in their day-to-day business operations and strategic planning. He also advocates on their behalf before the FDA, FTC, Customs, USDA, DEA, and other federal agencies, and in court. He is considered a leading authority in the areas of Generally Recognized as Safe (GRAS) requirements and New Dietary Ingredients (NDI); Ashish and his team do more NDI and GRAS projects than many of their competitors combined, and are known for their representation in the highest numbers of NDI matters submitted to FDA overall. Considered a creative and strategic partner by his clients, Ashish works with companies all over the globe and is a trusted advisor at every step of the product life cycle, including product formulation, safety and efficacy studies, product launch, and ongoing marketing and sales.
In addition to his pioneering background in FDA regulatory matters, Ashish is highly regarded for his wealth of knowledge on advertising regulations. He counsels clients on compliance issues and claims substantiation in connection with their advertising and marketing programs, and represents advertisers in both defending and challenging claims before the Better Business Bureau’s National Advertising Division (NAD) and other regulatory bodies.
In addition to legal advice, he prides himself on providing business-oriented solutions which minimize risks and enable his clients to reach their corporate goals. The companies with whom he works prize his immediate accessibility, his wide range of contacts in the regulatory arena, and his deep expertise gleaned from a sharp focus on this area of law. Prior to law school Ashish worked as a Chemist and a GMP auditor for the pharmaceutical industry. He also brings a tremendous amount of GMP experience to help respond to FDA 483’s and Warning Letters.
Ashish frequently publishes articles and presents at webinars and conferences addressing industry and legal subjects of developing importance. In his spare time, Ashish and his wife, a pediatric dentist, enjoy sharing their healthy lifestyle with their two young children.