About us

Regulatory Wisdom® is a renowned regulatory consulting firm headquartered in New Delhi, India. It was founded in 2009 by Dr. Rashmi Kulshrestha and is recognized for its industry expertise and comprehensive regulatory solutions.

We, at Regulatory Wisdom®, specialize in guiding clients through the complex regulatory landscape of the pharmaceuticals, biologics, medical devices, in-vitro diagnostics, cosmetics, foods and health supplements/nutraceuticals for India and international markets. Our services span from guidance in product development, pre- and post-marketing regulatory support, strategic planning and providing tailored solutions to meet the unique regulatory requirements of each market.

Regulatory Wisdom® assists the clients by guiding the product development in line with country specific requirements, data generation, document compilation for submission to various Regulatory Agencies all over the world, responding to queries and finally obtaining the approval of the products all under one roof. Registration being pre-requisite to market, Regulatory Wisdom® thus assists its clients for faster entry to new markets, enhancing their product portfolio and revenues, accomplishing right at first time, save efforts, time and cost.

In line with India’s ‘Make in India’ initiative, we also assist international clients in finding reliable local manufacturing partners, offering a cost-effective solution for entering the Indian market. By transferring production technology to local facilities, we not only help clients reduce costs but also contribute to India’s growing role as a global leader in cost-efficient pharmaceutical and healthcare production.

Our founder, Dr. Rashmi Kulshrestha, brings unparalleled professional experience of over 35 years. With a deep understanding of both local and international regulatory frameworks, Dr. Kulshrestha’s leadership has driven Regulatory Wisdom’s success in helping clients navigate the ever-changing regulatory environment.