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Navigating Chemistry, Manufacturing, and Controls Through the Drug Development Process

Review the CMC sections of regulatory submissions, the FDA inspection process, and how to avoid or minimize 483s (noncompliance) with this on-demand course.


Priya  Jambhekar

Priya Jambhekar

President, PBS Regulatroy Consulting Group, United States

Priya Jambhekar is a Regulatory and Quality professional with a background in early and late-stage development of Drugs, Biologics, Gene & Cell Therapy Products and Medical Devices in several therapeutic areas. Priya has significant experience of working with regulatory authorities in several countries including US, EU, UK, China and Japan and has developed successful strategies to support development and have prepared regulatory dossiers to support meetings with the regulators, investigational and marketing applications. Priya is a President and CEO of PBS Regulatory Consulting Group. Priya holds a MS degree in Pharmacy from St. John’s University and a MSc Degree in Organic and Biochemistry.