Dietary Supplement and Nonprescription Drug Consumer Protection Act

Dietary Supplement manufacturers are now required to report serious adverse events to FDA. PROSAR can help you put a process in place to document the case, determine whether a case is serious and prepare a MedWatch report when necessary.

PROSAR has been providing Adverse Event Reporting services for several years to the pharmaceutical industry. As a result, we already have the systems and processes in place to comply with FDA regulations and cGMPs making it easy for dietary supplement companies to quickly implement an AER system.