Mr Jaimin Patel has Master of Science in Toxicology degree from University of East London, UK, and an active member of British Toxicology Society. He is approved member in United Kingdom register of Toxicologist (UKRT) and European Registered Toxicologist (ERT). He has over 13years of pharmaceutical industry experience in Toxicology assessments. He is the only Qualified Person with MSc Toxicology in UK & EU.
- Permitted daily exposure (PDE) / Acceptable Daily exposure (ADE) reports for Active substances (PDE / ADE Reports) as per EMA/CHMP/ CVMP/ SWP/169430/2012
- Occupational Exposure Limit (OEL) for active substances that protects workers from potential adverse health effects during the manufacturing of pharmaceuticals.
- Elemental impurity risk assessment(EIRA) of Active substance or Finished product as per ICH Q3D
- Nitrosamine risk assessment of Active substance or Finished product as per EMA / MHRA Guidance
- Genotoxic impurity assessment of Active substance or Finished product as per ICHM8
- Toxicological safety determination of unknown Impurityas per ICHQ Q3B
- Module 2:Non-clinical dossier review and approval