Niyati Patel is a dynamic Quality and Regulatory Compliance leader with 19 years of experience in the pharmaceutical, biotechnology, and medical device industries. Currently serving as a Consultant Advisor at FDAQRC and previously as a Director at Sharp Services, Niyati specializes in digital transformation of quality management systems and regulatory compliance, ensuring adherence to global standards. Niyati holds a Bachelor of Science in Biotechnology from Kean University and a Master of Science in Biomedical Engineering from the New Jersey Institute of Technology. Their expertise includes risk-based validation strategies, inspection readiness, and cross-functional collaboration to optimize compliance processes.
This person is not in the org chart
This person is not in any teams
This person is not in any offices