About Us

Who We Are

PJI Biotech is made of team of Industry and Ex-Regulatory experts with expertise in Quality, CMC Quality, and Regulatory Compliance. Our team is knowledgeable of Regulatory requirements and Industry Best Practices.

Our Mission

To provide high quality services to customers.

Our Values

  • Be Innovative
  • Communicate Clearly and Directly
  • Treat Others with Respect
  • Collaborate to Create Long-term Value for Customers

Our Service Model

PJI Biotech provides strategic consulting services using PJI Biotech VDAES (Visioning, Designing, Aligning, Executing and Sustaining) Model.

We Deliver Results

We will do everything to meet or exceed your expectations.

Dipti Gulati

PhD, MBA, Founder

Dipti Gulati, PhD, MBA, is the Founder and Executive Consultant of PJI Biotech. Dipti Gulati most recently was the Executive Vice President, Pharma/Biotech at NSF International and VP/Vertical Head of Quality and Compliance at Syner-G Pharma. She was an organizing committee member for OMICS Biosimilar Conference and was a member of PDA Regulatory and Quality Advisory Board. Prior to that, she worked with senior leadership of large pharma companies, legal and financial firms such as Bain Capital, Morgan Lewis and Bockius, Lachman consultants, Genzyme etc., in a project/team leadership and Executive Consultant capacity. Previously, she held various leadership positions at Amgen, Emergent Bio Solutions, BioMerieux, Fujifilm Diosynth, and SmithKline Beecham. She has over 25 years of experience in the Pharmaceutical/Biologics industry, including 20+ years in quality and regulatory areas. She has a Ph.D. in structural characterization of medicinal products and an MBA in management. Her area of expertise is Quality risk management, Strategic Planning, CMC Quality/Systems and Inspection Readiness/Remediation. She helped manage and deliver on key project initiatives in companies like Bayer Biologics, Genzyme, Morgan Lewis & Bockius, Mylan, Dr. Reddy, Sun Pharma etc.

Expert Consultants

Our FDA Compliance Consultants and Regulatory Affair Consultants can provide customized solutions to solve complex Quality problems. 

Worldwide Affiliates

We have Collaborators in the US, EU, and APAC to provide a wide variety of Services in different Regions.