Best Practices for Developing High Quality, On Time Submissions Author: Steve Sibley2 Consolidating the scientific and regulatory information required to support a submission for marketing approval is a critical step for any drug development program. Yet many teams struggle with setting and adhering to a timeline for planning, drafting, reviewing, and editing the regulatory documents needed for the submission dossier. Here are some of the most common submission planning mistakes and tips for addressing them: Not knowing what “done” looks like: The experience gained by having been through the entire submission process from development through to defense, approval, and lifecycle management is invaluable. When you’re starting a new submission, identify which (if any) team members

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