Ressourcenblockade durch manuelle Dossier-Tracking
Definition
Komplexe Submission-Prozesse (klinische Daten, Expertenberichte, Risk-Management) erfordern manuelle Koordination, was zu Idle Time und Bottlenecks führt.
Key Findings
- Financial Impact: 40 Stunden/Monat pro Submission-Team (bei €100/Stunde = €4.000/Monat)
- Frequency: Kontinuierlich während Vorbereitungsphasen (3-6 Monate pro Zulassung)
- Root Cause: Fehlende digitale Tracking-Tools für Multi-Stage-Prozesse (Clinical Trials → Dossier → Submission)
Why This Matters
This pain point represents a significant opportunity for B2B solutions targeting Pharmaceutical Manufacturing.
Affected Stakeholders
Regulatory Specialists, Project Managers, QA Teams
Deep Analysis (Premium)
Financial Impact
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Current Workarounds
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Methodology & Sources
Data collected via OSINT from regulatory filings, industry audits, and verified case studies.
Related Business Risks
BfArM Einreichungsfehler und Verzögerungsstrafen
Fehlentscheidungen durch unvollständiges Tracking
Produktionsausfälle durch Serialisierungs-Engpässe
Verzögerungen und Bürokratie in der Änderungsfreigabe
Kosten der Abweichungsuntersuchung und CAPA
Bußgelder bei CAPA-Mängeln
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