All Document development articles

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    Journal

    Fundamentals of regulatory writing: the document development process

    2021-07-30T09:45:00Z

    Regulatory writers lead the development of high-quality regulatory documents by working in collaboration with colleagues across multiple functions. Document development is a multistep process with the regulatory writer acting as project leader. This article describes each of the stages of the process and suggests best practices for achieving timely project completion and document delivery