Because of the serious nature of breakthrough therapies, the FDA has a special designation to expedite review. That means a quick timeline and expedited access to advice meetings. ECG offers a streamlined version of our proven methodologies and proprietary tools to prepare your team quickly and efficiently while taking advantage of the increased possibilities for dialogue with your review division.
Short preparatory timelines are a challenge regularly met by ECG. But for breakthrough therapies, it is also leveraging the incremental meeting opportunities to collaborate with FDA that ECG can support during the preparatory sprint.
ECG’s significant first-in-class experience and success rate is at your disposal – we not only help you tell your approval story, but can provide unique visualizations and explanations that can influence the semantics and expectations of the therapeutic space you are pioneering for years to come.
Please contact us via email or at +1-201-894-8200 to discuss your needs or to get further information about our breakthrough therapy preparations.