Expedited reporting of case reports to Competent Authorities, EudraVigilance, FDA, Ethics Committees, Institutional Review Boards and Investigators
One of the most common causes of critical findings in Pharmacovigilance Inspections is non-compliance with the expedited reporting (15 day) of spontaneous serious adverse drug reactions. DADA has a quality system implemented to ensure that expedited reports are reported in time to competent authorities. Reports may be submitted electronically or by hard copy as required by local regulations. DADA is registered with EudraVigilance to facilitate electronic reporting. EMA-trained staff ensure compliance with the rigorous requirements of such a system. For medical devices, we can ensure timely incident reporting per applicable guidelines.