Safety

Preliminary consultancy, project definition and management.

SPECIFIC CONSULTATIONS AND PRODUCTS

  • OEL/OEB/ASL Assessment including engineering support for containment measures.
  • PDE Assessment for Medicinal Products/Active Ingredients in shared facilities (EMA/CHMP/SWP/169430/2012/00).
  • ERA for Medicinal Products for human use, as for EMEA/CHMP/SWP/4447/00, or Veterinary Use, as for VICH GL6 and VICH GL38.
  • E&L (Extractables and Leachables) on finished pharma products.
  • Impurity Safety Assessment (ICH Q3A, ICH Q3B and ICH M7), Genotoxicity, Toxicity and Risk Assessment.
  • Elemental impurities evaluation (ICH Q3D), Genotoxicity, Toxicity and Risk Assessment in Medicinal Products for human use or veterinary use.
  • Solvents evaluation (ICH Q3C), gentoxicity, toxicity and Risk Assessment.
  • “In silico” prediction for Toxicology (DEREK Nexus), Genotoxicity (SARAH Nexus), Metabolism (METEOR Nexus) and Degradation Products (ZENETH Nexus); interpretation of results and Expert Report by our ERT® (European Registered Toxicologist).