Pragnesh Panchamvedi

About Pragnesh Panchamvedi

Hello, my name is Pragnesh Panchamvedi. I am a Diplomate of American Board of Toxicology (DABT) and European Registered Toxicologist (ERT) with 13 years experience in diverse industries & consulting environments. I am a RAC certified from RAPS. I like to get updated myself regularly with developments in scientific & regulatory toxicology fields. I work to contribute towards making positive impact to work as well as safeguarding public health from risk.I hold Masters Degree in Regulatory Toxicology from reputed premier- National Institute of Pharmaceutical Education and Research (NIPER), Punjab, India. My Diverse Skill Sets are: • Derivation of Acceptable/Permissible Daily Exposure/Tolerable Intake (ADE/PDE/TI), Occupational Exposure Limit (OEL) for pharmaceutical active ingredients, impurities, residuals & solvents, extractables & leachables• Impurities Qualification in Drug Substance (DS)/ Active Pharmaceutical Ingredients (API) & Drug Products (DP) as per ICH/FDA/EMA guidelines (Q3 series and M7)• Preparation of Cosmetic Product Safety Report (CPSR), Product Information File (PIF), UK Cosmetic Products Notification (SCPN), EU Cosmetic Products Notification Portal (CPNP), Label and Claims Reviews• EU REACH (chemicals)/EU BPR (biocides)/ EU (pesticides) & EU CR (Cosmetics) regulations dossiers preparation including standard data exchange forms using IUCLID• CLP and GHS classification• Toxicological Risk Assessment and Risk/Benefit Analysis using best available scientific studies data (in vivo, in vitro, in chemico, in silico)• Help in generation of Next Generation Risk Assessment (NGRA) using New Approach Methodologies (NAM) like (Q)SAR, in-vitro/in-chemico, read across• Computational toxicology• Regulatory Writing (Nonclinical & Clinical)• Medical devices Biocompatibility Assessment (ISO 10993)• Help in evaluation of substances with potential endocrine disrupting properties (Endocrine disruptors)• Ability to interpret various types of complex regulatory as well as scientific data & to communicate clearly and concisely with detailed support as required for different industries• Responding to regulatory agencies and their designated notified bodies queries (i.e, FDA, EMA, ECHA, ESMA notified body)• Business Development and Digital Marketing (Social Media) communication strategiesDisclaimer: Post and shared updates/news are my own personal views. It does not necessarily represent my company or employer views or support.

Experience

1. Manager - Regulatory & Toxicology Services

   Intertek

   Jun 2024 — Present · Mumbai, IN

Education

• A.R. College of Pharmacy, Sardar Patel University, VV nagar, Gujarat

  Diploma in Pharmacy (DPharm), Bachelor of Pharmacy (BPharm), Pharmaceutics, Pharmaceutical Chemistry, Pharmacology, Pharmacognosy, Pharmaceutical management

  2005 — 2010

• National Institute of Pharmaceutical Education and Research (NIPER) ,SAS NAGAR , Mohali

  M.S. PHARM, Regulatory toxicology

  2010 — 2012

• H & D Parekh Highschool

  Higher secondary, Mathematics, Science, Physics, Chemistry

  2001 — 2005

Skills

• Analytical Chemistry
• Pharmacokinetics
• Personal Care Products
• Household & Laundry Product Safety Assessment
• Regulation (Eu) No 528/2012
• Global Product Stewardship
• Genotoxicity
• In Silico Toxicity Prediction
• Molecular Toxicology
• Medical Device
• Product Stewardship
• Toxicology Risk Assessment
• Toxicology and Regulatory Affairs
• Substance Review
• Glp
• Medical Devices
• Clinical Pharmacology
• Hazard Communications
• Personal Health Care Safety
• Product Safety and Regulatory Affairs
• In Vitro
• Fmcg
• Chemical Safety
• Iso 10993
• Regulatory Intelligence
• Regulatory Affairs
• Lifesciences
• Data Analysis
• Chemistry
• Personal Health Care (Phc)
• Modelling
• Global Product Safety (Gps)
• Regulatory Strategies
• Registration
• Glp (Oecd, Fda, Epa)
• Consumer Product Safety
• Pre-Clinical Safety Assessment
• Safety/Risk Assessment
• Biocide
• Human Safety Toxicologist