The globalization of the food, pharmaceutical and consumer product industries is driving harmonization of regulations. However, although there are growing similarities, there are boundaries to approval that must be overcome. There is growing pressure to get new products out and into the global markets. Safety, benefit, legality and economic viability will always be the product drivers, however, a global marketing strategy for companies should be informed not only by an awareness of the commonalities in regulation or science, but by the obstacles and challenges that persist in the global marketplace.
Spherix has a network of internationally recognized consultants around the world to assist our clients with questions about global product approval strategy and work to achieve successful regulatory submissions and product approvals.
Consultants:Silvia Berlanga de Moraes Barros, MSc., PhD
Dr. Barros is a toxicologist with over 30 years of experience in academia. She is an independent international resource consultant working with Spherix to provide strategic, scientific and regulatory guidance for clients in the area of risk assessment and ADME for the chemical and pesticide industry.
John Howlett, BSc
Mr. Howlett is a consultant in the United Kingdom with more than 37 years of experience in food regulatory and scientific affairs. He is an independent international resource consultant working with Spherix to provide strategic, scientific and regulatory guidance for clients.
Tetsuo Satoh, Ph.D.
Dr. Satoh’s is an independent international resource consultant, with more than 40 years of experience, working with Spherix to provide strategic, scientific and regulatory guidance for clients. His primary research interest is the molecular mechanisms of metabolic activation of pharmacologically active chemicals.
S.K. Gupta, M.Sc, Ph.D, D.Sc.
Dr. S.K. Gupta is currently Dean and Director General of the Institute of Clinical Research in India, which is one of the premier and pioneering institutes in the country. He was formerly Head of the Department of Pharmacology at All India Institute of Medical Sciences (AIIMS), New Delhi, and also the founder of National Pharmacovigilance center at AIIMS.
Guohua Zhou, Ph.D.
Dr. Zhou is an analytical chemist with over 20 years of experience in industry and academics. He is a consultant with Spherix, providing strategic, scientific and regulatory guidance in China. Dr. Zhou also serves as a professor in Nanjing University, a professor in China Pharmaceutical University, and a professor in Nanjing Medical University.
For more information, please contact us at info@spherix.com.