The process begins with an initial consultation to clarify the problem, affected product or system, regulatory context, urgency, available evidence, and desired decision or deliverable. XGene then defines the scope, priorities, responsibilities, and review approach before moving into assessment or implementation. Work may include document and data review, gap assessment, risk prioritization, strategy development, drafting, remediation governance, or follow-up verification, depending on the engagement. The purpose is to create a practical plan that is scientifically defensible, operationally executable, and proportionate to the client’s risk.
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