Technical documents sent to FDA (e.g., protocols, study reports and statistical analysis plans, SAPs) must contain sufficient detail so that FDA reviewers will agree with your company’s results and conclusions.

I am an expert at writing documents with the precise level of detail needed by FDA reviewers to do their job.

“Good Review Management: FDA’s Internal Standards and Expectations of Industry”

“Implementing FDA’s 2008 Guidance on the Integrated Summary of Effectiveness (ISE)”

⁽¹⁾ Contact me and the table of contents from any class can be emailed to you