🇩🇪Germany
Fehlentscheidungen durch unvollständiges Tracking
2 verified sources
Definition
Ohne zentrales Tracking-System werden Ressourcen für Submissions investiert, die scheitern, was zu Budgetüberschreitungen führt.
Key Findings
- Financial Impact: €100.000+ pro fehlgeschlagener Submission (Dossier-Kosten + verzögerte Einnahmen)
- Frequency: 1-2x pro Jahr pro Pipeline-Produkt
- Root Cause: Manuelle Excel-Tracking ohne Integration zu CESP/ELSTER
Why This Matters
This pain point represents a significant opportunity for B2B solutions targeting Pharmaceutical Manufacturing.
Affected Stakeholders
C-Level Executives, Portfolio Managers, R&D Directors
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
€50.000-€200.000 pro verzögerter Zulassung (6-12 Monate Opportunity Cost bei €1M+ jährlichem Produktumsatz)
Ressourcenblockade durch manuelle Dossier-Tracking
40 Stunden/Monat pro Submission-Team (bei €100/Stunde = €4.000/Monat)
Produktionsausfälle durch Serialisierungs-Engpässe
€10,000-€50,000 per day downtime; 5-15% capacity loss
Verzögerungen und Bürokratie in der Änderungsfreigabe
20-40 Stunden pro Change Request; €10,000+ pro verzögerter Produktion
Kosten der Abweichungsuntersuchung und CAPA
20-40 Stunden/Monat pro CAPA; Rework-Kosten 2-5% der Produktionskosten
Bußgelder bei CAPA-Mängeln
€10.000-500.000 pro Audit-Versagen; typisch €50.000+
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