Solve Regulatory ProblemsConsulting Services


Advantages of Hiring FDASmart

Classes We Developed So Others Can Learn From FDASmart Experience (1)

Analyzing regulatory problems and explaining their solutions arising from questions posed by FDA reviewers or issues that originate from the design, execution or analysis of clinical trials and clinical data.

Because We have worked on both sides of the regulatory fence having both created and reviewed submissions, We understand how reviewers think and work. For us, FDA actions and reactions are predictable.

“What Needs To Be in a Product Submission – An FDA Reviewer’s Perspective”. The class explains how reviewers think and work.

“Avoiding Statistical Errors in Clinical Trials: Preparing for FDA Review”

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

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