Global Case Processing
Global case processing is a compliance‑critical element of any pharmacovigilance (PV) system. Pharmaceutical and biotechnology Marketing Authorisation Holders (MAHs) are required to ensure the timely and accurate processing, medical assessment, and submission of Individual Case Safety Reports (ICSRs) across all markets where their products are authorised.
Biomapas supports MAHs with controlled, inspection‑ready global case processing, ensuring consistent execution, regulatory compliance, and transparent oversight across regions, regardless of case volume or organisational complexity.
Working within a defined governance framework, we provide end‑to‑end support across the full ICSR lifecycle, including:
- Structured identification and intake of safety cases from all reporting sources
- ICSR data entry, quality control and medical review
- Follow‑up management directly with reporters or in cooperation with your affiliates and partners.
- Regulatory submission and partner exchange of ICSRs
- SLA‑driven performance management and audit‑ready documentation
Alignment with Regulatory Expectations
Our operating model aligns with established international and local guidance associated with ICSR processing and integrates seamlessly into your existing pharmacovigilance system.
We are able to work within your existing safety database or within the safety database of Biomapas (Veeva Vault Safety). Our experience includes leading platforms such as Oracle Argus, ArisGlobal LSMV, Veeva Vault Safety, and other widely used safety database systems.
