Medical Writing of Submission Documents

Facet’s medical writing services include authoring and coordination of cross-functional reviews for regulatory submission documents including competitive product labeling content and risk management in the context of the current market landscape, US regulations, and guidances for that product.

An essential part of a company’s success is being able to convey what is known about their product in a clear and compelling way that regulators will understand. At Facet, we excel at interpreting data and creating consistent messaging across regulatory submission documents. From the simplest of cover letters to the most complicated of response documents, Facet’s regulatory scientists prepare, QC and finalize documents that are written with the reviewer in mind. Our approach leads to fewer questions (several of our approved NDA applications had entire sections where there were no FDA questions!) and faster approvals.

For those Sponsors who choose to author their own documents, we provide expert-level reviews from the regulator’s perspective with a focus on scientific integrity and completeness.
 

Facet’s Experience

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Supported Orphan Drug Designation Requests
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Worked on Breakthrough Therapy Designation Requests
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Pediatric Waivers and iPSP
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Supported Orphan Drug Designation Requests