Dr. Kulwant Saini
A professional par excellence with a strong academic background in pharmaceutical sciences, Dr.
Kulwant Saini boasts of more than three and half decades of experience in the pharmaceutical and
medical device industry. CliniExperts is proud to have Dr. Saini on the advisory board.
With a career spanning 22 years of meteoric rise in Johnson and Johnson alone, Dr. Saini has deftly
handled various aspects of pharmaceuticals and Medical Technology, ranging from regulatory affairs,
quality management system, research, clinical affairs, drug development to technology and product
assessment. He holds comprehensive industrial experience as regards medical device design control,
risk management, manufacture, and QMS to life cycle management.
His on-site experience is fortified by skillset in due diligence, licensing, acquisitions, deals, and
alliance management on the business management front.
He has well rounded knowledge of ISO, GCP, GLP, US FDA, EMEA, MDR/IVDR and other regulations
on the regulatory front.
His expertise in technical writing, QMS assessments of organizations/Certifying bodies and immense
experience have made him an indirect shaper of the Medical Device regulations in India.