The Pharmaceutical and Food Industry is heavily shaped by regulation which vary across countries greatly. Regulatory Wisdom, founded in 2009 by Dr. Rashmi Kulshrestha, is a renowned regulatory consulting firm, based in New Delhi, India, with a global presence. Catering to domestic as well as international clients, all dealing with different regulatory norms, Regulatory Wisdom has garnered vast experience through its 13 years of existence. The firm provides a whole range of services including assistance in product development, pre- and post-marketing technical and regulatory assistance, strategic assistance, among other offerings. Regulatory Wisdom makes it easier for companies to launch new products in the market that comply fully with local regulations.
Regulatory Wisdom offers an all-inclusive solution to its clients by providing strategic planning through regulatory intelligence: specified or targeted help in product development based on local regulation, valuable inputs to market strategy, help in determining product claims (primarily applicable to OTC, Food, and cosmetic products), sale, distribution, and warehousing of products in compliance to the regulation. Regulatory Wisdom helps the clients by preparing dossiers for submission to various Regulatory Agencies, assisting with resolving queries raised by them, and much more. The firm aims at enhancing the market portfolio and revenues of the clients by enabling them overcome regulatory hurdles and finding a quicker way to enter new markets.
Promoting the ‘Make In India’ Initiative
In alignment with the ‘Make in India’ initiative, Regulatory Wisdom often advises its clients (who are looking to enter the Indian market) to find a trustworthy local manufacturing partner and transfer production technology, so that products are manufactured locally. This not only helps promote the Made in India Initiative but also benefits the client in terms of cost-efficiency. This is an important factor in product development and sales in price-sensitive markets like India, where marketing imported products like food, drugs, and cosmetics is daunting. This helps generate more employment opportunities as well as puts India on the path to becoming a global leader in the cost-efficient production of pharmaceuticals. “We help foreign companies find a suitable trusted partner in India who can be their Authorized
Agent. This is a pre-requisite for registration of their drugs, biologics, and medical devices at The Central Drug Standards Control Organization, (CDSCO), the agency which regulates drugs, biologics, medical devices, and cosmetics in India”, speaks Dr. Rashmi, Founder, Regulatory Wisdom.
From Development to Sale
Regulatory Wisdom assists clients from the first step of product planning to the last stage of sales and distribution. With their in-depth knowledge of regulatory norms, they enable clients to launch novel food items or ingredients into different markets. In case a novel ingredient is denied permission by the regulatory agency, Food Safety and Standards Authority of India, Regulatory Wisdom has been able to help its clients by filing appeal applications directly with the chairperson of FSSAI. This has often led to clients getting permission to market novel/non-specified ingredients after minor alterations or fulfillment of the certain conditions recommended by the Agency.
Dr. Rashmi says, “We, as a regulatory consulting firm, work towards assisting clients in developing a marketing authorization application, supported by current scientific evidence. This is done in accordance with the requirements of respective countries in order to get regulatory approval for the innovation, which is a pre-requisite for marketing.” Upon completion of the registration process and successful market entry, Regulatory Wisdom also helps clients in finding apt marketing techniques and promotion advertisements for their products in compliance with the local regulation, finding optimal distributors who are trusted in the pharmaceutical industry, and encouraging sales. All of these require strategic planning with regards to the product as well as the company.
Expansion in the future.
Within its plans for expansion and development, Regulatory Wisdom is not only looking to grow the company but also actively contributing towards the growth of Indian regulatory norms. “Currently, India does not have an OTC regulatory framework. Regulatory Wisdom has assisted in preparing a draft OTC regulatory framework for India as part of a project with the Organization of Pharmaceutical Producers of India (OPPI). The proposal has been submitted to the Central Drugs Standards Organization (CDSCO)and the draft regulation is expected to be released in the public domain soon. Once finalized, it will form the new regulatory framework governing OTCs in India”, shares Dr. Rashmi. As far as its own plan of expansion is concerned, Regulatory Wisdom is actively expanding its presence globally by partnering with overseas companies and establishing operating offices there. They also encourage their foreign clients to market their products in India and other emerging markets. Regulatory Wisdom works towards finding clients who wish to promote affordable and effective treatment options across the globe and helps them in the process.
Dr. Rashmi Kulshrestha, Founder
Regulatory Wisdom was founded by Dr. Rashmi Kulshrestha in 2009. With over 30 years of professional experience, Dr Rashmi earned a Ph.D in Pharmacy, MBA in Marketing and a Diploma in Quality by Design (QbD) for Pharmaceutical Development. She has authored over 15 technical articles and 6 research papers. She is a former member of the editorial board of Scrip Regulatory Affairs Journal UK and of the Scientific Panel of Contaminants in Food Chain of Food Safety and Standards Authority of India (FSSAI). Prior to forming her own firm, Dr. Rashmi Kulshrestha was employed by Ranbaxy Laboratories Ltd.(later acquired by Sun Pharmaceutical Industries Ltd.),one of India’s largest pharmaceutical companies. Working for 18 years in that organization, she rose up to the rank of Associate Director. During her time in Ranbaxy, she worked very closely with Food and Drug Authorities of India to usher in regulation of food supplements so that products like Revital could be regulated correctly. This culminated in the enactment of the Food Safety and Standards Act 2006, which governs food/ health supplements and nutraceuticals under Section 22.
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