Dipti Gulati, Ph.D., MBA
Executive Vice President, Pharma and Biotech
Pharma and Biotech
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 characterization 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 organizing committee member for OMICS Biosimilar Conferences and was a member of the PDA Regulatory and Quality Advisory Board.
Her area of recognized expertise includes:
- Quality management (GLP, GMP, GCP) for pharma and virtual companies
- Baseline compliance audits and remediations
- Quality risk management and strategic plannin
- Regulatory readiness
- PAI readiness for pharm and virtual companies
- GMP inspection readiness
- Regulatory due diligence for merger and acquisition
- Quality unit start-up (QC/QA/compliance)