No human research protection program is immune from an OHRP Determination Letter or FDA 483 or Warning Letter. The best administrators realize it is how they respond to findings from federal agencies that will ensure that their organization is protected from additional sanctions and that the credibility of their HRPP remains intact.
With over 100 years of combined experience working as FDA and OHRP officials, AAHRPP Council Members and Site Visitors, as well as research administrators and IRB managers, we’ve been on both sides of the regulatory oversight process. We can use this experience to help you develop comprehensive responses to federal agency observations.
For more information about how we can help, please contact us at (347) 862-9321 or by email at email@example.com.