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pharmaceuticals · regulatory affairs · root cause analysis

Drug Filing Delays Fishbone

Tipo Diagrama de IshikawaNorma Ishikawa (1968) cause-and-effectMecanismo schematex-fishboneAtualizado 26/06/2026
Drug Filing Delays Fishbone
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O cenário

A pharmaceutical company faces repeated delays in filing new drug applications, risking market access and compliance. This analysis maps out potential root causes across multiple domains.

O que há neste desenho

Entenda as decisões por trás dele.

01

Prioritize process and system improvements

02

Enhance training programs

03

Implement real-time tracking dashboards

When diagnosing delays in regulatory submissions, especially for eCTD-based filings, and aiming to identify systemic issues.

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