Founded in 1993 and headquartered in Dortmund, Germany, PHARMSOFT Dr. B. Rodust GmbH is a specialist provider of pharmacovigilance (PV) software and services.
The company offers its proprietary GxP-compliant pharmacovigilance database, saphëus®, under a SaaS model, alongside a broad range of regulatory PV services. PHARMSOFT primarily supports small and mid-sized pharmaceutical companies across the DACH region, many of which are long-standing members of the ‘Pharma Deutschland’ association.
PHARMSOFT combines 30+ years of industry expertise with in-house technical development to provide efficient, secure, and regulatory-compliant solutions for drug safety data management. Its offering includes case processing (ICSRs), medical writing, regulatory submissions, report preparation (PSURs, DSURs) and literature surveillance – customizable via a modular service model.
The database saphëus® ensures compliance with international PV standards, including E2B(R2/R3), and supports multi-tenant secure access, case tracking, coding with MedDRA® etc.
As part of CERTANIA’s Life Science segment, PHARMSOFT will work closely together with SocraMetrics, forming a strong partnership. This move enhances CERTANIA’s position in the pharmacovigilance market by adding a strategic software component to its full-service PV offering, while expanding PHARMSOFT’s reach and capabilities.