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

  1. Regulatory Operation Specialist Ii

    Fortrea

    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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Prashant Gupta — Regulatory Operation Specialist Ii at Fortrea in Mumbai, MH, IN | Unifers