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Hazard Identification and Risk Assessment


Hazard identification and risk assessment for Pharma, Cosmetics, Agrochemicals, multi-component formulations, and Chemicals to assess safety used in Cleaning Validation/Occupational Exposure Limits/Biological evaluation for medical Devices/Toxicology Assessment for Pharmaceuticals/in-silico genotoxicity/Carcinogenesis assessment of impurities/Hazard Identification/metabolite prediction/assessment of relevant exposure details/providing succinct and comprehensive toxicology reports.

Vittarthaa provides expert toxicologist reports for in-silico assessment of drug impurity profiling for Genotoxicity & Carcinogenesis, MSDS, Cleaning Validation, HBEL assessment - developed and standardized regulatory documents for in-silico toxicity assessment on impurity, ADE/PDE, OEL & OEB derivation for submission to various regulatory agencies – MHRA, other European agencies, USFDA, Australian, Canadian, etc., prepared as per the VICH GL18 Residual solvents in new veterinary medicinal products, active substances and excipients and Pharmaceutical Inspection Co-operation Scheme (PIC/S), Risk-based manufacture of pharmaceutical products (Risk-MaPP), ICH, and other relevant references. Vittarthaa has vast experience in the derivation of Impurity profiling on Genotoxicity & Carcinogenesis, Toxicological assessment that were performed for several drugs/API/fine chemicals manufacturers in Europe, USA, Asia, and RoW.