Drug Regulatory Electronic Affair Management
DREAM is an integrated software solution for Product Database and Regulatory Process Management, supporting the work of people working in Regulatory Affairs, being compliant with all the strict deadlines. DREAM provides a flexible environment, which can be easily adopted to the needs of users.
Actually available DREAM modules:
- Core Product Database
- Process Management & Consignment Tracking
- Handling and archiving of SmPCs, PILs, Labels and MAs (management of additional document types can be integrated easily)
- Clinical Trial Module (CT Module)
- Pharmacovigilance Module (PSUR tracking and electronic CIOMS solution)
- xEVMPD compliant reporting tool
References:
DREAM is in place at numerous pharmaceutical companies, active locally, or on multinational level, including Sandoz in Hungary.