We structure, digitize and store the registration dossier data for pharmaceutical companies
QPPV
Regulatory Manager
Medical
Director
CEO/
Owner
Document exchange with the regulatory authority
Automatically receive and send adverse reaction messages in xml format to the regulator
Your data is protected
Automatic data backup and audit trail saving
Validated System
The system is validated by an independent company. Validation certificate is provided at the beginning of the cooperation.
Support
User support from 9-00 to 18-00 on business days by telephone, letters without restrictions.
Literary search
Literature search in specialized sources and automatic regular search with a given frequency.
MedDRA
Latest MedDRA Guide (24.0)
Automated reporting
Automatic building up of PSUR and downloading in Word format.
Access levels
Fine setting up of different access levels for different categories of personnel in your company.
Dossier audit
Initial audit of the dossier during the uploading of documents into the system in CTD format.
Analysis of available data, identification of customer needs
Transfer of medicine data and adverse events to the database
Intro Live Training for customer employees
Additional training as needed, training for new users
Regular technical support within the contract period
