Project delays Limited resources Study bottlenecks Inadequate documentation Non-integrated project team Unclear path forward

Establish drug development plan Provide 'needs assessments' Streamline operations within team Determine 'Go/No Go' strategies Identify required resources Strength/weaknesses analysis Contingency planning Support regulatory documentation and filing

Inadequate documentation Understaffing Poor QA/QC Delayed filings Problems with vendors Audit failure

Establish documentation system Develop SOPs Identify QA/QC requirements Supplement resources, where needed Vendor audit to establish compliance

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