ICSR submissions are sent electronically and, in some instances, manually across the globe. Qinecsa handles these submissions across all formats and modes, ensuring reliability as well as quick service, to ensure 100% regulatory and business partner compliance.
Professional, reliable, and trustworthy expedited submissions and partner distributions with a streamlined preparation process, tracking prompt and accurate communication to ensure first-time-right submission.
Our regulatory experts verify the accuracy and completeness of the ICSR submission packages, ensure client reviews, and perform submissions through Gateways, health authority web-portals, eFax, emails and through postal submissions.
Business partner distributions
Based on the safety data exchange obligations (SDEA), our pharmacovigilance specialists distribute the pertinent ICSR packages to necessary third parties via Gateway and emails maintaining timeliness and quality of submissions.
Based on SDEA obligations, periodic reconciliations are performed with partners to measure compliance. Regulatory and partner compliance metrics are tracked and reported to clients periodically to provide oversight.