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Strategic Quality and Regulatory Management Consulting

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Dipti Gulati, Ph.D., MBA, is the President and Executive Consultant of PJI Biotech. Previously, she held various management positions at Amgen, Emergent Bio Solutions, BioMerieux, Fujifilm Diosynth, and SmithKline Beecham. She has over 20 years of experience in the healthcare industry, including the 20 years in quality and regulatory areas. She has a Ph.D. in Structural Characterization of Medicinal Products and has authored several articles in reputed journals on structure-function relation of proteins and cell surface carbohydrates, quality metrics, FDASIA, Brexit and biosimilars. She is an organizing committee member for OMICS biosimilar conferences and a member of the PDA Regulatory and Quality Advisory Board.

Conference Presentations

Emerging Biosimilars in Therapeutics (2015)

Biosimilar Development Cost: Role of Analytics (2016)

Brexit and Biosimilars (2016)

Data Integrity: Opportunities and Challenges (2019)

Quality Management Systems: Clinical Research vs. Manufacturing, and Quality Culture (2019)


Quality Metrics: An Ongoing Journey (PDA Letters, April 2016)

FDASIA and its Impact on Global Drug Supply Chain (PDA Letters, July 2015)

28 publications in reputed journals on high order structure Interaction between glycoprotein and carbohydrates 

Our Team

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Dipti Gulati

President and Executive Consultant