Dr Prabha Bhandari

Regulatory Affairs

Dr Prabha Bhandari is the Vice-President (Regulatory Affairs) at the Council for Healthcare and Pharma (CHP). She is a Global Regulatory Affairs Professional and has over three decades of experience in the Pharmaceutical Industry with expertise in Global Regulatory Affairs covering various aspects of product development.

She has an in-depth understanding of R&D Functioning for Process Development, Technology Transfer, Quality, Operation, Data Integrity and Reliability as well as Creation of Quality Systems in the Organization for ensuring GMP and Regulatory Compliance.

Prior to this, she has worked in the capacity of Vice-President, Head – Corporate Quality Assurance – API Manufacturing in the biggest Indian Pharmaceutical Company and was responsible for all Quality Systems (including Quality Control, Quality Assurance and Stability Management Systems) and compliance of quality operations at all API manufacturing sites. She had successfully implemented harmonized Quality Management Systems in alignment with Global Quality Policies & Standards across all API manufacturing facilities through operating procedures, training, validation, maintenance and documentation resulting in enhanced compliance at sites. She played a key role in accomplishing GMP Compliance Certification of all API manufacturing facilities from Global Regulatory Agencies (Viz. US FDA, European Medicinal Agency, PMDA Japan, TGA Australia, COFEPRIS Mexico, ANVISA Brazil, CDSCO India, etc). She has also worked as Vice-President- Regulatory Affairs in one of the biggest Indian Pharmaceutical Company and did a lot of hand-holding with various Indian and International Pharmaceutical companies for strengthening their Regulatory Affairs functions.

Dr Prabha holds a Ph.D. degree in Organic Chemistry from Central Drug Research Institute, Lucknow, India with 5 years of Post-doctoral Research Experience from various European Universities (viz. Trinity College, Dublin, Ireland, University of Strathclyde, Glasgow, Scotland and the University of Nottingham, England). She has many scientific publications to her credit and represented her company at various international forums.