FDA is placing a growing emphasis on safety reporting. There are numerous deadlines to meet and reports to write. FDA’s definition of key terms is also important.

We can conduct a compliance gap analysis, write any missing SOPs and organize your efforts so your safety compliance efforts are complete and correct.

“A Survey of Adverse Event Reporting Requirements for Drugs and Biologics”

“A Survey of Medical Device Adverse Event Reporting Requirements”

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