Whether they are looking to market and sell pharmaceuticals, medical devices, biologics, dietary supplements, or food ingredients in the United States, Indian firms, like companies from any country, are subject to the regulatory scrutiny and compliance risks posed by the U.S. Food & Drug Administration (FDA). Many of our attorneys have worked in industry and regulatory bodies and have a long history of taking clients, both domestic and international, through the FDA’s paces. We have helped our large, multinational, India-based clients identify and address risks that might occur at any point in the product life cycle, design compliance programs, and understand the complex statutory and regulatory issues they are bound to face.
Alston & Bird has worked with our India-based clients to prepare their executives for regulatory meetings, to provide evidence to help lift import alerts, and to address FDA warning letters, as well as respond to untitled letters—much of this work on-site at multiple locations in India.