Pharma

Preliminary consultancy, project definition and management.

SAFETY – 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).

Regulatory Affairs – SPECIFIC CONSULTATIONS AND PRODUCTS

  • 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.

Candidate profiling to pre-clinical development – SPECIFIC CONSULTATIONS AND PRODUCTS

  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).