An astounding business leader and a proficient Pharma Regulatory Consultant, Dr. Rashmi Kulshrestha is the Founder & CEO of Regulatory Wisdom, a renowned India-based regulatory consulting firm, with a global presence. Through Regulatory Wisdom, she is transforming the Food & Pharmaceutical industry by contributing meaningfully towards regulatory filings required by Regulatory Agencies and obtaining approval on the initial attempt thereby effectively saving their clients’ time, effort, and cost.

Before switching to regulatory affairs, Dr. Rashmi learned analytical method development and acquired abundant practical experience with analytical instruments. Her research involved ICMR projects on Aflatoxins and Pesticide residues, which are of great concern both in foods and herbal drugs. Consequently, Dr. Rashmi was invited to serve on the first Scientific Panel on Contaminants in the Food Chain by the Food Safety and Standards Authority of India (FSSAI). Furthermore, her doctoral research experience helped her understand the science behind drug development, which she leveraged while interacting with scientists at pharmaceutical companies. Her multi-disciplinary training is an advantage as she is able to understand the expectations of the marketing team and enables her to bridge the gap between the R&D and marketing department within a pharmaceutical company.

High business ethics & good time management coupled with in-depth knowledge of the regulatory landscape enables Dr. Rashmi to cater to most major multinational pharmaceutical companies and she strives to inculcate these values in her team members to foster organizational growth. Let’s hear it from Dr. Rashmi Kulshrestha as she talks about her journey and more.

What motivated you to establish Regulatory Wisdom? Tell us about its most unique features.

I always wanted to start my regulatory consultancy firm, inspired by my father, who was an arbitration consultant. There are mul- tiple advantages of leading an independent consulting firm: no retirement age, flexibility in work, and there is no compulsion to cater to all clients; we do not work with clients whose thought processes and ethics are unaligned with ours. Above all. I believe, hard work as a consultant always pays off and is most often duly rewarded.

My venture, Regulatory Wisdom, is a provider of technical, scientific, and regulatory support for pharmaceuticals, biologics, medical devices, cosmetics, foods, and food supplements for India and other markets. We advise firms in these sectors from product concept to launch; both pre and post-approval compliance.

Tell us about the various responsibilities you shoulder as the primary leader of the organization. What are some of the key strategies that you employ for driving business growth?

As the primary executive, I oversee both business development and execution. My team members and I advise firms by drawing upon our technical, scientific, and regulatory knowledge and experience. We believe in taking incremental steps and modifying strategies based on learning from previous outcomes. We never compromise on the quality of our work even in face of stringent timelines that require extra effort, and ensure that our clients are always satisfied with our deliverables. This helps us retain our existing clients while attracting new ones.

"Our passion, hard work, and uncompromising attitude toward the quality of work is our success mantra"

Shed some light on the most critical business challenges faced by pharma regulatory consultants. What steps do you think can be taken to overcome them?

Regulatory consulting requires a lot of trust and integrity as confidential information on the quality, safety, and efficacy of products is shared with us regularly. Therefore, companies require a professional and ethical partner that is fully compliant with the present regulation. Most major pharmaceutical companies in India have regulatory departments and only small or middle-sized companies require external consulting. This is distinct from other regulated markets such as the US and Europe, where pharmaceutical consultants are hired because of their rich experience dealing with different types of applications in various markets.

What are some of the most significant milestones that you have achieved throughout your professional journey? What has been your success mantra?

Our most significant achievement is to attract foreign clients and establish a global presence through networking with local regulatory professionals in each market. Our passion, hard work, and uncompromising attitude toward the quality of work is our success mantra. This led our company, Regulatory Wisdom, to be adjudged one of the Top 10 Medical Devices and Pharmaceutical Regulatory Consultants in Asia by the Asia Business Outlook Magazine 2022 in just over a decade of founding.

In your opinion, how important is family support for aspiring women entrepreneurs in achieving their goals?

I believe support from family is imperative for the professional growth of women. Partners, parents, and in-laws must help support young women early in their careers by taking care of children while their mothers are at work. I was indeed fortunate to enjoy the support of my parents-in-law. During my grueling job at Ranbaxy, which often involved outstation travel and long hours, my children were looked after by their grandparents. Without the mental burden, I was able to concentrate on my regulatory work and research.

Dr. Rashmi Kulshrestha, Founder & CEO, Regulatory Wisdom

Having a Ph.D. in Pharmacy, MBA in Marketing, and a Diploma in Quality by Design (QbD) for Pharmaceutical Development, Dr. Rashmi has a rich professional experience of over 30 years handling projects across sectors for various markets: pharmaceuticals, biologics, medical devices, cosmetics, foods, and food supplements.

Awards & Recognition:

• Digital Entrepreneur of the Year Award (2016) for creating a niche in regulating the Food and Pharma Industry for Public Health in a ceremony held in 2016 at IIT Delhi,

• Among Top 10 Medical Devices and Pharmaceutical Regulatory Consultants inAsia (Asia Business Outlook.