Prof. Dr. B P Nagori

Co-Founder

Pharmaceutical consultants are in high demand due to the fast-growing global pharmaceutical business, which is expected to be worth over $1.6 trillion by 2024. This is especially true as the industry struggles with regulatory requirements and technological improvements. The consulting industry saw tremendous change, with the rapid digital revolution and heightened regulatory scruti­ny that followed COVID-19. Consultants are becoming in­dispensable for managing the complexity of compliance, quality control, and regulatory obligations. This paradigm shift has highlighted how important GxP (Good Practice) consultants are to preserving compliance and encouraging innovation in a more regulated and complex business.

Based out of Jodhpur, Rajasthan, India, Satori One Click Solutions provides comprehensive legal, regulatory compliance, and QA-QC management consulting services under one roof, focusing on the pharmaceutical and healthcare product industries. Satori One Click Solutions offers a wide range of services such as US Agent services, India Agent Services, Canada Agent Services, medical device and cosmetics licensing, natural health products and pharmaceutical formulations licensing, and preparation of SOPs, dossiers, and quality manuals.

The firm is an expert in labeling and other regulatory services, intellectual property issues such as patents, copyrights, and trademarks, and the creation and submission of Drug Master Files (DMFs). The firm also offers online certificate courses and training programs, along with customized consultancy and advisory services, to make sure that clients meet all necessary regulatory requirements efficiently and effectively.

What differentiates Satori One Click Solutions from other players in the industry is its foundation by a diverse group of technocrats, educationalists, and law professionals. This enables the firm to specifically address the complex demands and advantages of its clients. "We have our presence in three countries and significant industrial experience, which spans more than 60 years cumulatively. Our experts excel in listening to client needs, providing honest and unbiased opinions, and offering effective solutions to regulatory and compliance challenges in the pharmaceutical and healthcare product industries," conveys Prof. Dr. B.P. Nagori, Co-Founder of Satori One Click Solutions.

Driving Excellence through Expert Leadership

The leadership team of Satori One Click Solutions is renowned and has extensive experience and knowledge in the healthcare and pharmaceutical sectors. Prof. Dr. B.P. Nagori, from India, holds advanced degrees: B.Pharm.(Hons.), M.Pharm., M.B.A., Ph.D., and LL.B. With around 40 years of diverse experience in manufacturing, teaching, research and development, administration, and consultancy, he leverages his extensive network of alumni, many of whom occupy top industry positions globally.

Avinash K Arora, based in Canada, brings over 20 years of experience in the pharmaceutical and healthcare sectors. His background includes high-level management roles in business development, regulatory affairs, scientific affairs, and compliance for global companies that produce pharmaceuticals, food products, cosmetics, natural health products (NHP), over-the-counter (OTC) products, medical devices, and generic pharmaceuticals. Prof. Dr. Rakesh Gupta, also from India, is a former Professor and Principal at L.B.S College of Pharmacy in Jaipur. With degrees in Pharmacy (B.Pharm. (Hons.), M.S., Ph.D.) and over 40 years of experience in teaching, pharmaceutical production, quality assurance, and administration, he has also been a member of the Academic Council at Rajasthan University of Health Sciences, Jaipur, and the Quality Management Sub-committee at IDMA, Mumbai.

Business & Revenue Model

The firm aims to generate revenue in both the Indian and foreign markets through its global presence. Targeting first the USA, Canada, and India, the business intends to grow by setting up more offices abroad and extending its offerings to include more state regulatory bodies and healthcare-related goods. The three types of revenue and pricing models are fee-for-service, which charges a set amount for each hour or day of services provided; unit-based, which bills for each work unit produced; and project-based, which charges a one-time price for the duration of the project.

Navigating Global Regulatory Challenges

Global regulations governing pharmaceutical and healthcare products are quite strict and necessitate permits, approvals, and extensions for a variety of operations, including import, export, sales, manufacture, and distribution. It takes certain knowledge and experience to navigate this complicated regulatory environment. Due to the dynamic nature of the regulatory environment, both new and established businesses confront substantial hurdles in maintaining legal and regulatory compliance.

For instance, the Drugs and Cosmetics Act in India now applies to medical devices, requiring all medical device manufacturers. new or old, to comply. Comparably, on a global scale, medical device manufacturers must switch to the new regulations as the European Medical Devices Regulation has superseded previous directives. The need for regulatory competence is further highlighted by the government's active encouragement of new entrants and the expansion of established firms in the pharmaceutical and healthcare product industry, as India becomes a prominent producer of these goods.

“All of our QA-QC management, legal, and regulatory compliance consulting and advising services are available under one roof at Satori One Click Solutions. We have experience of working with regulatory agencies from around the world, including the USFDA, Health Canada, EU, CDSCO, EDQM, MHRA, and TGA. We specialize in serving the pharmaceutical and healthcare product industries, helping ensure that our clients successfully and efficiently comply with all applicable regulations,” concludes Prof. Dr. B.P. Nagori.