REGULATORY WRITING
It is estimate that the average general physician saves 4.7 lives per year; a medical writer can potentially save many more.
Regulations, guidelines and working within standard operating procedures are an increasing fact of life. It is not enough to deliver great research and then present the data, everything now has rules, lists and tick boxes. No wonder that the demand for regulatory writers is growing. Many in our team like the structured approach to document-writing and are keen to do more.
PROJECTS WE WERE INVOLVED IN
From CSRs to FDA petition
A project that we are particularly proud of involved writing a series of Clinical Study Reports (CSRs) for an orphan drug with a novel mechanism of action for the treatment of epilepsy. Along the way, we assisted in the production of an FDA petition. This involved reviewing over 5000 publications. The product has now received FDA approval for the first two of many planned indications.