Some information cannot be reliably inferred from uploaded files. Examples include design intent, commercial launch plans, exact material grades, unpublished clinical rationale, or the manufacturer’s chosen PMS activities.
When a gap request appears, answer with the specific fact requested and attach or reference supporting evidence if available. Avoid broad narrative answers when a precise value, date, material, or rationale is needed.
After you submit an answer, the expert may approve it, ask for changes, or use it as input to regenerate affected documents. Rejected answers should be revised in the same workflow so the decision history remains visible.
Official references
This article is practical product guidance, not legal advice. Confirm regulatory deadlines and obligations against current official sources and your assigned expert.