Rashmi Kulshrestha runs the pharmaceutical regulatory consultancy Regulatory Wisdom in New Delhi, India. Dr Kulshrestha was previously Associate Director – Regulatory Affairs at Ranbaxy Laboratories Limited in Gurgaon. She has 20 years’ experience in the pharmaceutical industry in varied areas, such as regulatory, analytical research and innovation management, including 13 years in regulatory affairs for filing generics (prescription products) and over-the-counter drug products and food supplements in Central and Eastern Europe, CIS, the Middle East, South East Asia, Central and Latin America and Eastern & French West Africa. Further, she has experience in the registration of drug products and food supplements in India; is well versed with the Drugs and Cosmetics Act 1940 and Rules 1945, which regulate drugs; and with the Prevention of Food Adulteration Act 1954 and Rules 1955, which regulate food and food supplements.