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pharmaceuticals · regulatory affairs · root cause analysis

Drug Filing Delays Fishbone

種類 特性要因図規格 Ishikawa (1968) cause-and-effectエンジン schematex-fishbone更新日 2026/6/26
Drug Filing Delays Fishbone
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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.

この図に含まれるもの

図の背後にある意思決定を読み解く。

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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