Pharma

• 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).

• Site Master File.
• AIFA notification.
• DMF preparation (e-CTD format) Europe, Canada and USA.
• CEP (Certificate of suitability) preparation and submission support.
• Suitability dossier.
• Plans and report for process validation, cleaning and analytical.
• Stability protocols.
• SOPs (Standard Operating Procedure).
• Specific Risk Assessment.
• Pre-audit GMP and inspection to non-EU manufacturer’s sites in cooperation with ILC Srl.
• Training.
• Temporary Manager for assistance to QP and QA managers.

1. Candidate profiling: “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).
2. First into man: selection of the testing panel, CRO selection, Study Monitoring, Expert Report.
3. Full Pre-clinical development: selection of the testing panel, CRO selection, Study Monitoring, Expert Report.

Study Monitoring and Expert Report done by our ERT (European Registered Toxicologist).