From Expert Reports to Pharmacovigilance
Medical scientific service is the core competence of Diapharm-partner Dr. Ebeling & Assoc. GmbH. For our clients we research adverse drug reactions, elaborate pre-clinical and clinical expert reports as well as Periodic Safety Update Reports (PSUR).
Dr: Ebeling & Assoc. GmbH implement reliable pharmacovigilance systems improving the safe use of medicinal products. Besides that, the Diapharm specialists assume responsibility as Pharmacovigilance Commissioner / Qualified Person Pharmacovigilance for our clients.
In the marketing authorisation sector, Dr. Ebeling & Assoc. produce pre-clinical and clinical expert reports (CTD-Modules 2.4 to 2.7) as well as clinical assessments of medical devices. In our services we attach great importance to compliance with all international standards.
Regular searches of scientific literature and the analysis of spontaneous reports form the basis for the identification of an adverse drug reaction report (ADR). Our pharmacovigilance experts perform this task. We detect relevant findings in scientific literature and evaluate spontaneous reports. We prepare the formats for reporting and file single case reports. We elaborate Periodic Safety Update Reports (PSUR) and of course also perform eletronic ADR reporting for our clients.
