McKinsey September 16, 2021
Gaurav Agrawal, Jennifer Dikan, Michelle Lyons, Rosa Poetes, and Maha Prabhakaran

By rethinking the approach to regulatory submissions, pharma companies can reduce timelines and increase their chances of successful product approvals.

To get new products to market faster, pharmaceutical companies are increasingly looking to their regulatory submissions not only for opportunities for improvement but also as a focus area for strategic capability building. A submission is a multidisciplinary endeavor, and it requires careful orchestration across R&D and commercial functions over the year—or longer—that it takes to develop a filing strategy and prepare the dossier for a regulatory agency.

We define submission excellence as the ability to prepare, in industry-leading time frames, high-quality regulatory submissions that accurately represent relevant data and maximize the likelihood of first-cycle approval with a favorable...

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