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Dr K S Rao

Board Certified Independent Toxicology Consultant

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About K S Rao

Dr. K. S. Rao is a globally recognized toxicologist with over five decades of experience in safety evaluation across pharmaceuticals, agrochemicals, industrial chemicals, medical devices, and nutraceuticals.

He began his career in 1971 at G.D. Searle, USA, and went on to hold senior roles at Dow Chemical and Quintiles. On returning to India, he led toxicology divisions at Jai Research Foundation (Gujarat), Advinus Therapeutics, and Syngene International (Bangalore).

Dr. Rao has been instrumental in advancing toxicological strategies for hundreds of companies worldwide, with expertise spanning discovery toxicology through IND and NDA filings. His work has shaped regulatory submissions to authorities such as the FDA and EPA (USA), EMA (Europe), PMDA (Japan), and Indian regulators. He is the principal author of over 500 safety evaluation study reports and has published and presented extensively in international journals and conferences.

A pioneer in the field, Dr. Rao is:

  • Emeritus Member, Society of Toxicology (SOT), USA – the first Indian toxicologist honored with this status after 40 years of active membership.

  • Recipient, Lifetime Achievement Award (Society of Toxicology of India – STOX) for outstanding contributions to the field.

  • Recipient, Toxicologist Mentor Award (SOT, USA) – the first Indian-origin scientist to receive this recognition in SOT’s 60-year history.

A driving force behind bringing the Diplomate of American Board of Toxicology (DABT) examination to India in 2009, enabling over 90 Indian toxicologists to qualify in the past decade.

In recent years, Dr. Rao has focused on supporting drug developers in designing testing strategies and determining first-in-human (FIH) doses based on preclinical data, bridging science with regulatory expectations to enable safer and faster development of new therapies.

Highlights

Experienced executive R&D leadership 

Widely recognized for developing innovative toxicological methodologies, mentoring teams, and advising clients on strategy, testing, and regulatory compliance in drug safety.

Over five decades of leadership in toxicology and safety assessment, guiding global pharma, biotech, and CROs in advancing preclinical development programs

Research in Hepatotoxicity (Michigan State University College of Veterinary Medicine)

Postdoctoral Fellow in Hepatotoxicity (Case Western Reserve University, USA)

Ph.D. in Toxicology (First Class) (National Institute of Nutrition, India)

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