Dr Rashmi Kulshrestha

Founder & CEO

The advancing pharmaceutical sector in India is experiencing tightening regulatory norms to ensure safety of medications, leading to an increase in the demand for regulatory consulting services. However, these services are largely demanded by small and medium sized pharmaceutical firms that lack internal regulatory facilities. The majority of big Indian pharmaceutical companies only demand consulting services externally when planning to expand their presence overseas. Contrary to this, big companies in regulated markets, especially those in the U.S. and UK, choose regulatory consultants who bring specialized experience such as former US-FDA and UK MHRA officials.

To help foreign and Indian companies navigate the complex Indian regulatory framework, Dr Rashmi Kulshrestha founded Regulatory Wisdom. Currently positioned amongst the top Medical Devices and Pharmaceutical Regulatory Consultants within Asia, the company offers value-driven services. Transcending beyond the role of a service provider, it serves the clients as a reliable partner, supporting them in their endeavors to expand into the Indian and international markets.

Facilitating Seamless Market Entry

The firm provides clients with a broad range of services spanning from product concept to assisting registration of the medicinal products in the target region, and launch. Serving across diverse geographies, the company tailors its strategies to maximize effectiveness by adhering to the global practice of using International Council for Harmonization (ICH) guidelines on quality, safety and efficacy for data generation. Utilizing these strategies, the company customizes strategies to align with the diverse regulatory landscapes across different countries, thereby facilitating seamless market entry.

To eliminate time, cost, and effort duplication, the company guides clients to develop their medicinal products and generate associated data systematically, registering them first in emerging markets. Regulatory Wisdom simultaneously takes proactive measures to guide the company to generate additional data to meet regulatory requirements in more regulated markets, streamlining the process for the clients, while enabling them to generate revenue from these emerging markets. Beyond these services, the firm also provides extensive guidance and audits for post-approval regulatory compliance, including GMP audits. The clients are updated about latest regulations through newsletters and communications about any changes in GMP guidelines, good warehousing and distribution practices, pharmacovigilance and more.

Experts in preparing registration dossiers in various formats, the dynamic and agile team at Regulatory Wisdom adopts a multifaceted approach to stay abreast of the evolving documentation requirements mandated by global regulatory agencies. Emphasizing staying current with the evolving national and international standards, the team regularly analyzes notices issued by regulatory agencies, REGULATORY WISDOM DRIVING SUPPORT TOWARDS PHARMACEUTICAL COMPANIES TO MAKE THEIR MARK IN NEW MARKETS Dr Rashmi Kulshrestha, Founder & CEO and updates its databases to align practices with the latest developments.

“Our regulatory team regularly monitors official publications, websites, and newsletter updates from Regulatory agencies such as the FDA (USA), EMA (EU), TGA (Australia), Health Canada (Canada), MHRA (UK), CDSCO (India) and other countries across the globe. This is complemented by the regulatory authority’s databases that provide real-time updates on new guidelines, rules, and legislation”, states Dr Rashmi Kulshrestha, Founder & CEO, Regulatory Wisdom.

Participation in conferences, webinars, and professional networking events are also part of the company’s effort to stay ahead of changes in both the industry and regulatory landscapes. These measures provide it an edge in preparing dossiers by enhancing alignment with latest standards and guidelines. The team also undergoes continuous training and development, refining their expertise, and knowledge.

Expanding Consultancy Services

Committed to enhancing its services with the advancing regulatory demands of the industry, the company has ambitious plans for the future. The firm is working relentlessly to enhance its regulatory intelligence services that equip clients with advanced analytics and insights into global regulatory trends. It aims to leverage the vast database at its disposal, along with AI-powered tools to provide more predictive and proactive guidance.

As it looks ahead, it remains steadfast in its goal of adding value for its clients, expanding its services to meet the growing demands of the pharmaceutical, biotechnology, and medical device sectors. The company is also focusing on service expansion for niche segments like biotechnology and gene therapies, where regulatory requirements are highly specialized. To achieve this, the company has plans to develop specialized teams of experts who can provide indepth regulatory support, from pre-clinical stages to postmarketing regulatory compliances.

Regulatory Wisdom further aims to expand its global footprint by enhancing presence strategically in regions that are experiencing significant growth in healthcare and life sciences. The team aspires to assist clients navigate these varied regulatory frameworks, establishing its competence across diverse regulatory frameworks.

“Our ultimate goal is to continue evolving our services, leveraging technology and innovation to provide our clients with the most strategic, efficient, and compliant pathways to market. Whether through expanding our geographic reach or developing new areas of specialization, we are committed to staying ahead of the curve”, adds Dr Rashmi.

Aligned with this goal, Regulatory Wisdom is exploring emerging specialization areas such as digital health technologies, including telemedicine, digital therapeutics, and AI-driven solutions as well. Recognizing the potential of these sectors, the firm is developing expertise in these areas. Simultaneously, it is also expanding its services to assist clients with regulatory risk management, empowering them to effectively be prepared for the impact of evolving regulations. Blending these comprehensive strategies, the firm not only aims to strengthen its presence and relevance, but also aspires to continually add value for its clients.