ICH - Guidelines
ICH Q8-Q9-Q10-Q12: step-by-step operational guide
Implementing Q8, Q9, Q10, and Q12: Operating method, checklist, and pitfalls to avoid.
ICH Q8-Q9-Q10-Q12: step-by-step operational guide
Implementing Q8, Q9, Q10, and Q12: Operating method, checklist, and pitfalls to avoid.
ICH E Guidelines: how to pass audits and inspec...
Prepare for EMA/FDA inspections: correctly apply the ICH E Guidelines on sponsor oversight, TMF, data integrity and risk management. Guide for QA/QP.
ICH E Guidelines: how to pass audits and inspec...
Prepare for EMA/FDA inspections: correctly apply the ICH E Guidelines on sponsor oversight, TMF, data integrity and risk management. Guide for QA/QP.
ICH M7: How to Manage Mutagenic Impurities Step...
Practical ICH M7 Guide: identification, classification, TTC limits, and control strategies. For QA, QC, and RA.
ICH M7: How to Manage Mutagenic Impurities Step...
Practical ICH M7 Guide: identification, classification, TTC limits, and control strategies. For QA, QC, and RA.
ICH Q8-Q9-Q10-Q12: practical guidelines for the...
Understanding Q8, Q9, Q10, and Q12: The global framework that guides quality, risk, and lifecycle management.
ICH Q8-Q9-Q10-Q12: practical guidelines for the...
Understanding Q8, Q9, Q10, and Q12: The global framework that guides quality, risk, and lifecycle management.
ICH M Guidelines: how to pass FDA/EMA audits wi...
Audit-proof strategies for CTD/eCTD dossiers compliant with the ICH M Guidelines. Reduce deficiencies and critical findings.
ICH M Guidelines: how to pass FDA/EMA audits wi...
Audit-proof strategies for CTD/eCTD dossiers compliant with the ICH M Guidelines. Reduce deficiencies and critical findings.