Scientific toxicological evaluations providing the foundation for cleaning validation and operational safety in pharmaceutical manufacturing.
Lumicure Pharma offers specialized toxicological risk assessment (TRA) services, providing the scientific foundation for cleaning validation and occupational safety. We specialize in Permitted Daily Exposure (PDE) and Occupational Exposure Limit (OEL) determinations, ensuring your operations align with ICH Q3C, Q3D, and M7 guidelines.
Our reports are prepared by certified toxicologists and are recognized by major regulatory bodies (FDA, EMA, SFDA), facilitating smooth market access and audit success.
Health-based exposure limits for active ingredients and impurities to support rigorous cleaning validation strategies.
Establishing safe workplace exposure limits to protect personnel handling potent compounds and APIs.
ICH M7 assessments for DNA-reactive impurities, including QSAR modeling and rigorous risk characterization.
Comprehensive risk assessments for N-nitrosamine contamination in raw materials and manufacturing processes.
Exhaustive toxicological data mining from global repositories.
Rigorous application of safety factors and HBEL formulas.
Dossier-ready certified toxicological documentation.