Ashish Talati

Ashish R. Talati is one of the industry’s foremost experts on FDA regulatory matters. 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); 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.

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.