Sharlin Consulting

Write SOPs GCP audit of CROs and Sponsors Solve Regulatory Problems Write Protocols and Study Reports Improve Submissions (Drugs, Biologics, and Devices) Audit Safety Compliance

In-House Computer Systems - Part 11 Compliance Commercial Software Products - Part 11 Compliance Improve SAS Programming

View This Month's Training Classes Part 11 Compliance (3 Classes) SOPs (2 Classes) Regulatory Affairs (7 Classes) Statistical Analysis (2 Classes) SAS Programming (3 Classes) Adverse Event Reporting (2 Classes) Entering Data into ClinicalTrials.gov (4 Classes)

In Progress

This section of SpeedUpFDA.com contains documents that are especially useful and possibly not well known. The FDA web site contains a lot of valuable information some of which is difficult to find. These selected documents will help you be more effective with FDA, describe the review process, and explain how to create reviewer friendly submissions. My intent is to publicize this important information and make it more accessible.

There will be frequent additions to this tab, so re-visit SpeedUpFDA.com for new documents to download.