PJI Biotech
PJI Biotech is a strategic consulting firm specializing in customized quality, compliance and regulatory solutions for pharmaceuticals, biologics, diagnostics and combination products. PJI Biotech provides FDA Regulatory Consulting services to clients on a global basis, in North America, Europe and Asia.
At PJI Biotech, we are focused on providing strategic consulting services with the highest levels of customer satisfaction. PJI Biotech has supported clients in strategic planning, PAI and GMP inspection readiness, enterprise compliance risk management, global remediation plan development and implementation oversight, global quality system development, complex CMC regulatory and quality issue resolution and CMC regulatory strategy development.
PJI Biotech can work with you as a trusted partner, strategic advisor or retainer for business guidance or support.
Why Choose Us?
Expert Business mentors are key for the success of business. That’s why we build our team with experts with decades of Quality and Compliance experience. We are client focused, result-oriented and knowledgeable of industry best practices and current global regulatory requirements. We develop customized solutions according to client requirements to meet client needs. We give each of our clients the time and advice clients deserve. We care for our clients. Whether you’re seeking a strategic alliance with the right partner or a special skillset or tool, call us today. Together we’ll create and refine your plan for success within competitive pricing and timelines.
Our Testimonials
“I cannot say enough about the fantastic job you (Dipti Gulati) did leading the project for our consent decree. Your expertise on lab quality was second to none and your management skills were outstanding. Your “can do” attitude and ability to deliver to the schedule were first rate. Thanks for all your help.”
“I would highly recommend Dipti Gulati to any firm in the pharmaceutical industry seeking timely insights and guidance from a seasoned quality professional. Dipti facilitated the development of a strong quality foundation and our ability to move our project steadily forward.” Our pleasure, Dipti. We really appreciate your contributions to our project!
“Dipti Gulati has been a critical and outstanding member of our team, bringing significant expertise, insight, and focus to our project. She has worked fluidly with us to develop a comprehensive strategy to successfully address our key objectives. Dipti is dedicated, thoughtful, an responsive, and it has always been a pleasure to work together.”
“Thanks, Dipti for helping us set-up Quality Programs for our products. Your advice on the management of Quality Operations was very helpful. I also learnt how to manage Quality Operations. I got more than what I expected to get out of the project.”