Submit once. Track everywhere.
Set each authority up once, route every ICSR automatically, and see every submission and acknowledgement in one place.
Regulatory operations and gateway teams.
Configure. Route. Report. Track.
One login with the rest of HAROM OnePV.
Every action audited
Role-based access · controlled workflows
- 1Configure
- 2Route
- 3Report
- 4Track
GatewayPRO, as your team sees it.
An illustrative view of your workspace.
Configure. Route. Report. Track.
What GatewayPRO does
Configure once
Every authority set up and reused.
Rules do the routing
The right case reaches the right destination.
Built to each authority
E2B(R3) generated per destination profile.
Secure AS2 exchange
Certificate-based, gateway to gateway.
Acknowledgements tracked
Matched to each submission; resend in one click.
Complete submission record
What went where, and when — searchable.
E2B(R3) submissions to
Electronic submissions configured, routed and tracked for every authority through HAROM GatewayPRO.
EMA EudraVigilance
European Union
US FDA
ESG · FAERS
UK MHRA
United Kingdom
Health Canada
Canada Vigilance
WHO PIDM
International Drug Monitoring
Standards and formats
Role-based access
Everyone sees exactly what their role allows.
Audit trail on every action
Who, what and when — always on record.
MFA or one-time code, enforced
Every sign-in verified twice.
Strict password policy
Strong, rotated, enforced.
Controlled workflows
Nothing skips a step.
Designed to support 21 CFR Part 11 and EU Annex 11 controls.
Configured, routed and tracked for every authority.
See it working
See GatewayPRO in a live walkthrough with a HAROM PV expert.