Dipti Gulati

Dipti Gulati, Ph.D., MBA

Executive Vice President, Pharma and Biotech

Health Sciences

North America

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Dipti Gulati is a quality executive with more than 30 years of pharma/biotech industry and consulting experience, including 20 years in quality and regulatory areas. She has a Ph.D. in structural characterisation of medicinal products and an MBA in management.

Dr. Gulati most recently led a quality and compliance vertical at Syner-G Pharma. She previously worked as an executive consultant to senior leadership at large pharmaceutical, legal, and financial companies (Bain Capital, Morgan Lewis & Bockius, Lachman Consultants, Genzyme and Bayer Biologics). She has held leadership positions at Amgen, FUJIFILM Diosynth, bioMérieux and SmithKline Beecham.

Dr. Gulati has authored several articles in reputed journals on structure-function relation of proteins and cell surface carbohydrates, quality metric, FDASIA, Brexit and biosimilars. She was an organising committee member for OMICS Biosimilar Conferences and was a member of the PDA Regulatory and Quality Advisory Board.

Her area of recognised expertise includes:

  • Quality management (GLP, GMP, GCP) for pharma and virtual companies
  • Baseline compliance audits and remediations
  • Quality risk management and strategic planning
  • Regulatory readiness
    • PAI readiness for pharma and virtual companies
    • GMP inspection readiness
    • Regulatory due diligence for merger and acquisition
    • Quality unit start-up (QC/QA/compliance)

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