PharmSoft offers GxP-compliant PV software and modular services for pharmaceutical companies

For more than 30 years, we have been developing software and services that make ensuring drug safety more efficient and reliable. Our GxP-compliant pharmacovigilance database saphëus® is operated as SaaS and supports complete case management – from ICSR recording and medical documentation to reports such as PSUR and DSUR. Automated workflows, structured case tracking, MedDRA coding and E2B-compliant interfaces ensure smooth, regulatory-compliant processes.

We also take on tasks such as literature research, regulatory submissions, signal management and the preparation of periodic reports. Small and medium-sized pharmaceutical companies in particular benefit from our modular service model, which can be flexibly adapted to scope and resources.

With the combination of technical development, data security and in-depth regulatory knowledge, we offer an integrated solution for modern pharmacovigilance – reliable, scalable and audit-ready at all times.