Dr. Gurjar

Regulatory Project Manager

Dr. Gurjar holds a Ph.D. in Biotechnology from the University of Pune, with doctoral research carried out at the CSIR–National Chemical Laboratory (NCL), India. She has over 15 years of combined experience in regulatory affairs, medical devices, clinical research, and academia. She specializes in USFDA medical device classification and submissions, with expertise in pre-submissions and 510(k) applications, and a strong understanding of De Novo, Breakthrough Device Designation (BDD), and PMA pathways.

She is proficient in ISO 13485 Quality Management Systems, 21 CFR Part 820 compliance, and MDR 2017 (India), and has managed audits, certifications, licensing, and CDSCO submissions. Her experience also includes clinical trial regulatory activities such as ethics committee approvals, CTRI registration, and clinical study documentation.

Recognized with fellowships including the DBT-BioCARe Woman Scientist Award and the IAS-NASI-INSA Summer Research Fellowship, Dr. Gurjar combines a strong scientific foundation with regulatory expertise to support medical device innovators in navigating global approval pathways.

 

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