We ensure the timely and accurate submission of safety reports to global regulatory authorities, maintaining compliance with all relevant guidelines and regulations. Our dedicated team manages the entire submission process, from data compilation to submission tracking, to ensure efficient and seamless interactions with regulatory agencies.
Case Management Submissions
Efficient submissions streamline PV processes: accuracy, speed, compliance, and collaboration. Trust our expertise for seamless case management.
Our regulatory experts guarantee precise and comprehensive ICSR submission packages, conducting client reviews and utilizing Gateways, health authority web-portals, eFax, emails, and postal submissions for expedited reporting.
Business Partner Distributions
Adhering to safety data exchange obligations (SDEA), our pharmacovigilance specialists promptly distribute relevant ICSR packages to required third parties through Gateways & emails, ensuring timely & high-quality submissions.
Reconciliations
In accordance with SDEA obligations, regular reconciliations are conducted with partners to assess compliance. We track & report regulatory & partner compliance metrics periodically to offer comprehensive oversight.
