The usual killers

• Unclear compliance mapping
• Missing certificates/docs
• Weak deviation handling
• Unowned responsibilities
• Late clarifications
• Inconsistent technical narrative
• Undefined execution plan
• Poor QA on deliverables
• No risk register
• No internal gate reviews
• Pricing not aligned with scope
• Last-minute packaging/format errors

Prevent it with 3 gates

• Gate 1: compliance completeness
• Gate 2: technical story + deviations
• Gate 3: submission readiness checklist

Rule: If it isn’t in the checklist, it doesn’t exist.