Dipti Gulati

Vice President Quality Assurance and Compliance

Dipti heads the Quality Assurance and Compliance team at Syner-G. She most recently was the Quality & Regulatory executive consultant for Lachman Consultants where she worked with the senior leadership of large pharma companies, legal and financial firms such as Bain Capital, Morgan Lewis and Bockius, Sanofi Genzyme, Bayer biologics, Mylan, etc., in a project/team leadership capacity. Previously, she held various leadership positions at Amgen, Emergent Bio solutions, BioMerieux, Fujifilm Diosynth, and SmithKline Beecham. She has over 20 years of experience in the Pharmaceutical/Biologics industry, including the 20 years in quality and regulatory areas. She has a Ph.D. in structural characterization of medicinal products and an MBA in management. Dipti has authored several articles in reputed journals on structure-function relation of proteins and cell surface carbohydrates, quality metric, FDASIA, Brexit and biosimilars. She is an organizing committee member for OMICS biosimilar conferences and was a member of the PDA regulatory and quality advisory board. Her area of expertise is Quality/CMC strategic planning, PAI/inspection readiness, due diligence for mergers/acquisitions, quality/compliance risk management, quality Operations management, quality systems, team leadership, and project management. Dipti resides at Morrisville, NC, she enjoys gardening, painting, reading and ice-skating.

Our Focus:

At Syner-G Pharma Consulting, Chemistry, Manufacturing and Controls (CMC) is our sole focus. We offer a complete suite of CMC solutions (CMC-360) in the following three core areas: Regulatory Affairs, Pharmaceutical Development, and QA/cGMP Compliance.

Contact Us:

Syner-G Pharma Consulting, LLC
371 Turnpike Road
2 Park Central Drive, Suite #110
Southborough, MA 01772
(508) 460-9700

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