Draft a Project Charter for regulatory submission projects specifying version control requirements, FDA correspondence protocols, and risk-based decision gates

Generate draft a project charter for regulatory submission projects specifying version control requirements, fda correspondence protocols, and risk-based decision gates for Other Professional, Scientific, and Technical Services industry

Other Professional, Scientific, and Technical Services

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Upload your preliminary regulatory dossier, IND/NDA documentation templates, or existing submission materials that need charter development
Select the specific regulatory pathway and complexity level affecting version control requirements and risk assessment
Specify the FDA center and division that will review your submission for correspondence protocol alignment
Specify detailed version control specifications including naming conventions, approval workflows, and change documentation requirements
Identify the primary risk categories for establishing decision gates based on regulatory impact severity
Define all project stakeholders, their roles in decision gates, and required approval authority levels
Select the primary FDA correspondence method based on submission type and urgency
Define specific milestone dates and deliverables for each risk-based decision gate checkpoint
Select applicable regulatory quality frameworks and standards that must be embedded in the charter
Provide detailed scope definition including what's in-scope versus out-of-scope for this regulatory submission iteration