Expert Details

Expert in Pharmaceutical Regulatory / Technical / Intelligence

Expert ID: 738259 India

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Expert is presently associated with an apex drug regulatory body in India as the Asst Drugs Controller and has been associated with the firm since August, 2003. He has a very diverse/extensive experience in the Healthcare Industry and is presently based in India. His Areas of expertise include: Pharmaceuticals in India, Regulatory Compliance, Bio Similars, Cosmetics, Drugs, Clinical Trials.

Further, Expert has a post graduate degree in pharmaceuticals which is duly recognized by the University of Toronto. He has evaluated more than 100 applications of Market Authorization / Clinical trials of biological new drugs in India. He is currently registered as expert at many reputed on line consultation firms and has attended international workshops and has presented India.

Education

Year Degree Subject Institution
Year: 1992 Degree: Master of Pharmaceutical Sciences. Subject: Pharmaceutical Institution: NAGPUR UNIVERSITY, NAGPUR, INDIA

Work History

Years Employer Title Department
Years: 2003 to Present Employer: Undisclosed Title: Technical Associate /Assistant Drugs Controller Department: Biological /s Various offices within
Responsibilities:
• Reviewed critically and submitted technical files pertaining to import and export of pharmaceuticals, new drugs, therapeutic proteins, medical devices, etc.
• Worked in a multi tasking environment for issuing various regulatory approvals and licenses, No Objection Certificates, etc.
• Responsible for technically reviewing applications pertaining to Clinical Trials/ Marketing Authorizations / Post Marketing Surveillance pertaining recombinant -DNA therapeutic proteins and monoclonal antibodies

Fields of Expertise

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