Prashant Gudhate

Prashant Gudhate has extensive work experience in the pharmaceutical industry. Prashant is currently serving as the President of Corporate Quality, Regulatory & Formulations at Fermenta Biotech Limited, where they have been working since 2014. In this role, they are responsible for formulating regulatory strategies and ensuring that quality systems meet international standards.

Before joining Fermenta Biotech Limited, Prashant held the position of Vice President of Corporate Quality Assurance & Regulatory Affairs at the same company. During their tenure, they provided leadership in elevating quality systems and formulating regulatory strategies to meet various authorities' requirements and customer expectations.

Prior to their roles at Fermenta Biotech Limited, Prashant worked as the Director of CQA at Dr. Reddy's Laboratories from 2012 to 2014, and as the Head of QA - BU API INDIA at Sandoz India Pvt Ltd from 2009 to 2012.

Prashant also served as the General Manager of Corporate QA & RA at AARTI INDUSTRIES LTD., INDIA, where they were responsible for designing and implementing quality systems to obtain regulatory authorities' approvals for manufacturing facilities and submission of regulatory filings.

Prashant’s career in the pharmaceutical industry started in 1986 as a Research Associate at Hoechst India Ltd. Prashant later worked as a Production Executive at Hoechst Marion Roussel Inc. from 1992 to 1996.

Overall, Prashant Gudhate has extensive experience in quality assurance, regulatory affairs, and formulation management within the pharmaceutical industry.

Prashant Gudhate has a Master of Science (MSc) degree in Organic Chemistry from Savitribai Phule Pune University. In addition, they have received certifications such as Lead Auditor for Quality Management Systems ISO 9000 from TÜV NORD GROUP in September 2009, and FDA approval for chemical & Instrumental analysis from FDA Maharashtra in August 2002.