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SafetyDrugs is a pharmacovigilance safety database developed by Italy-based Max Application srl, designed for adverse event management in clinical research and post-marketing surveillance. It supports the collection, management, transmission, and analysis of ICSRs for products such as drugs, medical devices, vaccines, and cosmetics. Built on an Oracle database, it is positioned not as a general-purpose CRM or ticketing system, but as vertical enterprise software for highly regulated industries.
The product covers the main pharmacovigilance workflow, including case entry, import, duplicate case search, work planning, message alerts, regulatory submissions, and reporting analytics. On the reporting side, it can generate line listings, CIOMS, PSUR, PBRER, DSUR, SMQ, MedWatch, MIR, audit trails, quality check reports, and more, with support for Excel export. Optional modules include Gateway, Converter, GDPR, Business Intelligence, Device, and Copy Case. Gateway enables ICSR submission to EMA, FDA, and MHRA; Converter supports ICH E2B R2/R3 conversion; and the GDPR module can mask sensitive data during XML extraction and report generation.
SafetyDrugs does not publish fixed pricing and is quoted on request. Costs depend on the number of users, number of sites, annual case volume, selected modules, migration needs, and validation support. The base package starts from 3 users and 1 site. Deployment is relatively flexible: it can be purchased as an on-premises license and installed on the customer’s servers, or rented as a SaaS deployment hosted in Oracle data centers. The SaaS offering includes backup, disaster recovery, and a 99% availability commitment. Implementation typically takes several weeks and includes data migration, staff training, system validation, and go-live. Support tickets can be submitted through a portal and are handled by internal technical, analytical, and professional teams.
Its strengths include deep specialization in pharmacovigilance workflows, clearly defined compliance modules, and support for multi-site isolation, making it suitable for pharmaceutical companies, CROs, group enterprises, and pharmacovigilance outsourcing service providers. Its validation support, GAMP5 documentation package, MedDRA updates, data backup, and GDPR mechanisms are valuable for regulated companies. The downsides are that pricing is not transparent and requires a quote; API and developer support are not clearly documented; and the available materials focus mainly on European and US regulatory frameworks, with no disclosed information on China-specific regulations, Chinese-language support, or localization capabilities.
Website and service accessibility in mainland China, payment methods, and RMB settlement are not specified, so they should be considered unknown. For Chinese companies targeting European or US submissions, SafetyDrugs can be considered as a candidate. If the primary focus is China’s domestic regulatory process, companies should also evaluate Oracle Argus Safety, ArisGlobal LifeSphere Safety, Veeva Vault Safety, as well as domestic vendors with localized experience in Chinese pharmacovigilance.
⚠ This review is compiled from public sources and does not constitute a purchase recommendation. Verify all facts on the vendor's official site. Verify on safetydrugs.it official site.
safetydrugs.it is an Italy Health provider. TG4G tracks its product information, an overall rating of 6.0/10, and a China-accessibility score of Limited (proxy recommended). Click "Visit Official Site" to reach safetydrugs.it directly.