- Keep a register of medicines conveniently.
- Get structured information about adverse reactions or lack of efficacy of medicines.
- Add instructions, related documents, and any other additional information.
- Search for literature in specialized scientific sources.
- Your information is comprehensively protected in accordance with applicable law.
Pharmacovigilance Safety Medicines Database
We structure, digitize and store the registration dossier data for pharmaceutical companies
OtiPharm® Data Pro
High-Tech in Pharmacy
We solve problems:
- Collection, processing and storage of adverse reactions data
- Receiving and sending data to the regulator in E2B R2 format
- Literary search (one-time and regular)
- Ability to use the latest version of MedDRA
- Downloading the CIOMS and 137 / o forms
- Report Tracker
- Saving medicine dossiers in CTD format
- Timing monitoring of the preparation of documents
- Regulatory Tracker
- Reports push-reminder
- Monitoring and visualization of the work of qppv and regulatory managers
- Audit by Regulatory authority, audit of the dossier completeness in CTD format
- Procedures monitoring
- Reports push-reminder
- Monitoring employee data entry online
- Secure storage of all dossiers
- Monitoring all regulatory services and pharmacovigilance procedures
- Automatic reporting
- Automation and optimization
Our main features
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
The system is validated by an independent company. Validation certificate is provided at the beginning of the cooperation.
User support from 9-00 to 18-00 on business days by telephone, letters without restrictions.
Literature search in specialized sources and automatic regular search with a given frequency.
Latest MedDRA Guide (24.0)
Automatic building up of PSUR and downloading in Word format.
Fine setting up of different access levels for different categories of personnel in your company.
Initial audit of the dossier during the uploading of documents into the system in CTD format.
System Implementation Steps
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