Solutions for Pharma Industries

Submission Management

eCTDmanager Suite - Electronic and Paper Publishing of medicinal product and medical device approval applications
RLPmanager - Report-level publishing with Hyperlinking and Study Management
DRAmanager - Integrated control and tracking of life sciences products and associated regulatory affairs processes
DOCmanager - A management component to maintain master submissions and associated regional submissions
DOCvalidator - Automated Document Format Compliance check for Word and PDF documents
EURS is Yours - The Agency eCTD Review and Validation System
GECCO (new)
Services

Document Management

DOCvalidator - Automated Document Format Compliance check for Word and PDF documents
DMSconnect - A configurable standardized connector for leading Document Management Systems
miniDMS - A basic layer for version control and LC management of regulated documents
Services

Pharmacovigilance Management

PcVmanager - Electronic management and reporting of adverse events based on the E2B standards
Services

Labeling Management