Prashant Gupta
Regulatory Specialist II- Fortrea | Specialist (Toxicology)- Tata Elxsi | Manager (Risk assessment) - SUN Pharma | Consultant- NPPA | Ranbaxy | Ganpat University | NIPER Mohali |
- Role
- Regulatory Operation Specialist Ii at Fortrea
- Location
- Mumbai, MH, IN
- LinkedIn followers
- 500 followers
About Prashant Gupta
With over 7 years of experience in toxicology and research, I am currently working at Tata Elxsi since June 2023. My primary responsibilities include preparing Toxicological Risk Assessment (TRA) reports for medical devices, conducting biocompatibility gap assessments in accordance with EU-MDR 2017/745, and engaging in CML activities.I completed my PhD from the Department of Pharmacology and Toxicology at NIPER Mohali, where I also earned my M.S. Pharm in Regulatory Toxicology. My role as a PhD research scholar at NIPER Mohali involved drug combination screening, handling tuberculosis bacteria, primary cell line culture, and working with endogenous opioids and peptide screening.In my previous roles, I was also involved in toxicology risk assessments for pharmaceuticals, HBEL report (PDE & OEL preparation, impurity qualification, genotoxicity evaluations using in silico software such as DEREK, CASE Ultra, Toxtree, and OECD QSAR Toolbox, Non-clinical summary preparation as well as INCI profile preparation for cosmetics and monograph preparation. Additionally, I have experience in conducting toxicity studies, research, and teaching activities. Previously, I worked at Sun Pharmaceutical Industries Limited (Drug Safety Evaluation department, GLP Lab) in Gurugram for 14 months. There, I was involved in various toxicity studies (acute, repeated dose, 4 days, 14 days, 28 days), which included animal handling, dosing, sample collection, blood withdrawal, necropsy, organ collection and weighing, data collection, and report preparation.I am now seeking opportunities in the field of toxicology to effectively utilize my research experience and continue contributing to research efforts.
Experience
Regulatory Operation Specialist Ii
Jun 2025 — Present · Mumbai, IN
Education
National Institute of Pharmaceutical Education and Research (NIPER) ,SAS NAGAR , Mohali
Doctor of Philosophy - PhD, Pharmacology and Toxicology
2016 — 2020
NIPER MOHALI
Master of Science (MS), Regulatory Toxicology
2012 — 2014
Guru Ghasidas University
Bachelor of Pharmacy (B.Pharm.)
2008 — 2012
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