E2B ICSR Exchange Flow
Streamline safety reporting with secure, compliant E2B data exchange.
Our E2B Configuration Capabilities
Streamlined Electronic ICSR Submission. Globally Compliant. Seamlessly Integrated.
ICH E2B(R2) & E2B(R3) Support
Full setup and validation for both E2B versions, including hybrid environments.
XML Message Mapping & Validation
Precise mapping of safety database fields to ICH-compliant XML, validated against global and regional schemas.
Gateway Configuration
Setup of secure transmission gateways (AS2, WebTrader, EV Gateway) with encryption and tracking.
Sender & Receiver Profile Management
Configuration for EudraVigilance OrgID, FDA ESG registration, and other authority-specific profiles.
MedDRA & WHO Drug Dictionary Integration
Automated import, mapping, and version control of key pharmacovigilance dictionaries.
Regulatory & Business Rule Setup
Apply regional validation rules to reduce rejections and ensure successful submissions.
ICSR Lifecycle Management
Support for all reporting types: initial, follow-up, amendment, and nullification.
Audit Trails & GxP Compliance
Complete traceability of all actions during the ICSR submission process.
Testing & Qualification
Pre-launch testing with regulatory agencies (e.g., EMA XCOMP, FDA ESG).
Expert pharmacovigilance solutions to safeguard patients, ensure compliance, and drive innovation in drug safety. Partner with us for precision, vigilance, and regulatory excellence.
India
India - Headquarters
Pristine City Bakori Road, Wahgoli, Pune, Maharashtra - 412207
+91 90283 33221
India - Development Center
Baba Somnath Tower, Bypass Ramur Road, TP Nagar Haldwani Uttarakhand 263139
+91 90283 33221
Australia
Australia Office
ACN: 664 913 928
38 Energy Dr lyndhurst VIC 3975, Australia
38 Energy Dr lyndhurst VIC 3975, Australia
+61 4 0461 3093