This White Paper Showcase explores the needs of regulatory affairs operations and the medical writing community in regards to the delivery of comprehensive, quality content, and uncovers the document-related risks associated with the submission process.

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Learning Objectives:
Identify challenges in the formatting process
Define the business drivers that support an optimal environment while alleviating risk
Highlight the importance of establishing a quality control gateway between the medical writing community and regulatory affairs Explore how to position a plan for effectively leveraging improvements in the quality process.