Regulatory strategy document

 

 

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team and with authorities. Planning tool: documentation of timelines and topics to be discussed with health authorities. Why a Regulatory Strategy? investigational new drug (IND), is crucial because it allows you to devise a development plan, a document for a path forward that describes the specificAn effective Regulatory Strategy is a living document . . . a planning tool to track key milestones and summarize critical development issues that impact The sponsor TPP and development plan are living documents and require regular monitoring and review to evaluate progress against objectives and updating as

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