Regulatory Submission Leadership

Regulatory submissions are major milestones!! We agree and celebrate in every company’s wins. Regulatory submission leadership involves managing the creation, review and finalization of regulatory submissions.  These activities require hard work, dedication, and strong leadership to be successful.  At Facet, we know that the greatest regulatory strategy doesn’t help unless you have a team that can flawlessly execute on the tactical implementation of that strategy.

Facet experts have led and supported countless regulatory applications.  We know how to align project teams toward a common goal, use tools of the trade to track submission components, and keep to strict timelines.  Our experience with regulatory submissions enables us to see problems before they arise and implement solutions so that your submission milestone is achieved on time, without drama or heroics.  Whether it’s an IND, NDA, or 510k, let us help you achieve your next regulatory milestone!
 

Facet’s Experience

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Successfully Submitted U.S. IND applications
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NDA 505(b)(1) Applications
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505(b)(2) Applications
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Supported Orphan Drug Designation Requests
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Worked on Breakthrough Therapy Designation Requests
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Facilitated Pediatric Waivers and iPSP
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Special Protocol Assessments (SPAs)
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Small Business Waivers