DIPTI GULATI, PhD, MBA

Executive Vice President, Pharm and Biotech, NSF, USA

Dipti Gulati is a Quality and Regulatory Executive with 30+ years of Pharma/Biotech industry, academia and consulting experience. She has a Ph.D. in structural characterization of medicinal products and an MBA in management.

Most recently, she was leading Quality and Compliance vertical at Syner-G Pharma.  Prior to that, she worked with senior leadership of large pharma companies, legal and financial firms (Bain Capital, Morgan Lewis and Bockius, Lachman consultants, Genzyme, Bayer Biologics etc.), as an executive consultant. Previously, she held various leadership positions at Amgen, Fujifilm Diosynth, BioMerieux, and SmithKline Beecham.

She 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 Planning
• Regulatory Readiness
  • PAI Readiness for Pharm/Virtual Companies
  • GMP Inspection Readiness
  • Regulatory Due diligence for Acquisition
  • Quality Unit Start-up (QC/QA/Compliance)