Gap analysis

Gap analysis is the process of identifying missing evidence, insights, or capabilities needed to meet strategic, regulatory, or stakeholder expectations.

What is gap analysis?

Gap analysis is a structured method used to evaluate the current state of evidence, strategy, or stakeholder alignment against defined goals or requirements. In pharmaceutical development, this often involves comparing existing data or capabilities to those needed for successful regulatory submission, market access, or clinical decision-making.

Why is gap analysis important in pharmaceutical strategy?

Gap analysis helps prioritize evidence generation, refine stakeholder engagement, and align cross-functional planning. It supports readiness for HTA submissions, advisory boards, or launch, and ensures that the most critical scientific and commercial needs are addressed proactively.

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