Submissions to FDA must have sufficient detail so FDA reviewers can understand and duplicate your key data analyses.

Because We understand how reviewers think and work, We can create reviewer friendly submissions that will anticipate and answer reviewer’s questions and issues. The result is faster approval time.

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

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

“Survey of FDA Reviewer Training: Understanding Reviewer Strategies, Tools and Techniques”

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