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Regulatory Publishing & Submission Toolkit

Ensuring compliant document formatting and dataset structure, managing timelines and expectations related to the submission, and laying the groundwork for efficient publishing might not be the most glamorous aspects of drug development, but they can make or break a submission.

In this toolkit you will find essential resources to help guarantee that your publishing and submission process is complete, timely, and fully meets regulatory expectations. We hope that you find this information useful for your program’s regulatory submission.

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Regulatory Publishing & Submission Toolkit