FDA Application Submissions and Negotiation

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When it comes to reviewing your FDA marketing applications for compliance with FDA regulations, we have the experience you need — especially if you are short on manpower, time, or specific knowledge. During the review process, we work directly with the FDA reviewing divisions to ensure your filings are reviewed in as timely a manner as possible, and that any substantive issues raised by the reviewers are resolved promptly. We also routinely work with and have access to a wide network of consultants (e.g., medical experts, pharmacologists/toxicologists, regulatory chemists, engineers, software experts, and investigators) when the need arises.

We will prepare you for guidance meetings and meetings with FDA advisory committees that are reviewing your applications. In the event the FDA seeks to impose conditions on a marketing approval, the team has experience crafting post-market surveillance studies, labeling revisions, and completing other projects to ensure those conditions are met. We also have significant experience in securing user-fee reductions or waivers.