Regulatory Dossier Due Diligence checklist.
Regulatory dossier evaluation.
1 600 Skr
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Purpose:
Provides a structured checklist to support the systematic review of regulatory dossiers as part of due diligence activities, focusing on completeness, consistency, and identification of potential compliance gaps.
Regulatory Alignment:
Aligned with EU regulatory expectations for marketing authorisation dossiers and lifecycle management, with relevance to EU GMP quality system oversight and ICH guidelines applicable to dossier content.
Included Files:
• Regulatory dossier due diligence checklist
• Sectioned review aligned to CTD structure
• Gap identification and follow-up tracking fields
Format:
Microsoft Word or Microsoft Excel (fully editable)
Intended Users:
Pharmaceutical manufacturers, regulatory affairs, quality assurance, and technical teams involved in dossier review, due diligence, and regulatory assessment activities.