In the ever-evolving landscape of the pharmaceutical industry, pharmaceutical regulatory consultants from India serve as valuable partners for pharmaceutical companies, providing essential guidance and expertise in navigating the complex regulatory landscape. Recent trends in India's pharmaceutical consulting industry include growing demand for regulatory consulting services, specialized consulting in pharmacovigilance and market research, leveraging digital technologies for drug development, and a focus on sustainability and environmental impact. Besides these, the pharmaceutical consulting industry encounters various challenges, such as navigating complex and ever-changing regulations, ensuring pharmaceutical product quality and safety, acquiring and retaining skilled professionals, managing cost pressures, and addressing global market dynamics.
Regulatory Wisdom, a leading regulatory consulting firm based in India, offers comprehensive services to guide clients through the product development process and expedite market entry across multiple countries. The firm addresses these challenges by providing comprehensive regulatory consulting services. From staying updated with evolving regulations to navigating global market entry requirements, streamlining approval processes, ensuring post-approval compliance, and developing tailored regulatory strategies, the firm offers expertise and guidance.
Regulatory Wisdom is a premier regulatory consulting firm that specializes in assisting clients in overcoming regulatory hurdles and achieving faster entry into new markets. “Our expertise lies in providing strategic planning and regulatory intelligence specific to each market, thereby enhancing our clients' market portfolio and revenues”, speaks Dr. Rashmi Kulshrestha. The company offers comprehensive regulatory support across a wide range of product categories, including pharmaceuticals (generics, IND/NDA, over-the-counter products such as ayurvedic, herbal, and chemical formulations), biologicals, medical devices, in-vitro diagnostic kits, food, food supplements, and cosmetics. By leveraging its deep understanding of the regulatory landscape and market-specific requirements, it guides clients toward successful product registrations and market launches, ensuring compliance and maximizing business opportunities.
Streamlining Regulatory Processes and Maximizing Product Potential
“We excel in guiding clients through the development of new products in different categories including pharmaceuticals, foods, health supplements/nutraceuticals, cosmetics, and medical devices, ensuring data generation aligns with country-specific registration guidelines. Our experienced team prepares tailored registration dossiers for submission to various Regulatory Agencies worldwide, utilizing the CTD format for pharmaceuticals where applicable”, says Dr. Rashmi Kulshrestha.
Regulatory Wisdom provides essential support in responding to queries raised by Regulatory Agencies and offers valuable regulatory assistance in post-approval compliance to meet ongoing obligations. For clients looking to expand their product reach, the firm aids in upgrading existing products through additional data generation for new markets.
The company’s services extend to the selection of suppliers for active botanical ingredients in herbal formulations using the Analytical Hierarchy Process. Furthermore, Regulatory Wisdom also offers regulatory perspectives on product sale, distribution, and warehousing, for prescription products, OTC (Ayurvedic/ Herbal and chemical) products, as well as food, health supplements/nutraceuticals and cosmetics, and medical devices. With its expertise, clients can confidently define product claims, and ingredient-based claims supported by scientific evidence for OTC products, food, food supplements, and cosmetics, adhering to advertising and labelling regulations.
By assisting with advertising and marketing promotional materials from a regulatory perspective, Regulatory Wisdom ensures clients to navigate the regulatory landscape with ease and achieve successful market entries while complying with all relevant regulations.
The company also provides technical and scientific guidance for in-vitro/in-vivo, nutritional studies, and clinical studies on finished products for obtaining differentiated claims and hence gets a competitive advantage. In addition, Regulatory Wisdom specializes in assistance in filing products containing novel food ingredients, new drugs, and new medical devices. The firm’s regulatory experts guide clients through the intricacies of regulatory submissions, ensuring all necessary requirements are met for the approval and market launch of these innovative products.
Driving Success through Ethical Regulatory Support
Regulatory Wisdom stands out from other firms in several key ways. The firm advises its foreign clients to transfer production technology to trusted Indian partners, enabling local manufacturing and embracing the "Make in India" initiative. This strategy reduces costs in the price-sensitive Indian market and facilitates the marketing of products like drugs, food, cosmetics, and medical devices. It also generates employment opportunities and reinforces India's reputation as a leader in cost-efficient pharmaceutical production.
“As a regulatory consultant, we prioritize integrity and trust. Companies entrust us with their proprietary product information, requiring a partner who exemplifies ethical behaviour and maintains full compliance with current regulations. Our regulatory checklists and robust pipelines ensure end-to-end support, from product ideation to approval”, shares Dr. Rashmi Kulshrestha.
With a focus on collaboration, innovation, and regulatory expertise, Regulatory Wisdom is confident in its ability to foster the development and accessibility of ground-breaking treatments while ensuring compliance with evolving regulatory requirements
Expanding Global Presence for Innovative Product Marketing
Looking forward to the future, the company plans to expand its reach by opening offices in collaboration with consulting firms in North America and Europe. This will enhance client service and relationships in those markets. The firm aims to assist clients in marketing their innovative products globally, including pharmaceuticals, biologicals, medical devices/in-vitro diagnostics, cosmetics, food, and food supplements. Regulatory Wisdom recognizes the potential of indigenous companies and start-ups abroad that have developed groundbreaking treatments for incurable diseases and improved drug targeting.
As regulations in these areas continue to evolve, the firm seeks to attract clients operating in biologics and computational drug development, offering comprehensive regulatory solutions. The goal is to promote affordable and effective treatment options worldwide while staying ahead of regulatory advancements.
Dr. Rashmi Kulshrestha, Founder & CEO
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.
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