Platform / Regulatory submission
Submissions that arrive right first time
Every E2B (R3) file is validated before it leaves, sent through the right gateway, and tracked until the acknowledgement comes back, against every regulatory clock.
Days left on every case
Rejected files flagged at once
Everything regulatory submission needs, in one place
Pre-submission validation
Every E2B (R3) file is checked against the schema, ICH business rules and the destination’s regional rules before it is sent.
- ICH E2B (R3) schema and business rules
- Regional rules for each destination
- Clear messages showing what to fix
- Files that fail never leave
Agency routing
Each case is routed to every authority and partner that needs it, based on your rules for products, markets and agreements.
- Destinations decided by product, market and case type
- Partner obligations included
- Routing rules versioned and approved
- Every routing decision recorded
| Destination | Rule | Deadline | Route |
|---|---|---|---|
| EMA | EU serious | 15 days | Gateway |
| FDA | 15-day alert | 15 days | Gateway |
| Partner [Name] | SDEA | [__] days | E2B exchange |
Gateway transmission
Files are packaged and transmitted securely through agency gateways and to partners, with every transmission logged.
- Agency gateway connections
- Secure, logged transmission
- Batch and single-case sending
- Retries handled automatically
ACK tracking
Every acknowledgement is tracked. Rejections are flagged straight away with the reason, so they can be fixed and resent within the clock.
- Every ACK matched to its file
- Rejections flagged with the reason
- Missing ACKs chased automatically
- Resubmissions linked to the original
| File | Destination | Sent | ACK |
|---|---|---|---|
| Case [ID] | EMA | [date] | Accepted |
| Case [ID] | FDA | [date] | Accepted |
| Case [ID] | EMA | [date] | Rejected · reason shown |
| Case [ID] | Partner | [date] | Awaiting |
Local requirements
Country and agency-specific requirements are configured for every market you report to, from formats to timelines.
- Local formats and fields
- Local timelines and destinations
- Language requirements where they apply
- Powered by Regulatory Intelligence
| Market | Format | Timeline |
|---|---|---|
| EU | E2B (R3) | 15 / 90 days |
| United States | E2B (R3) | 15 days · periodic |
| [Market] | [Format] | [Timeline] |
Placeholder rows for markets configured at setup.
Audit-ready archive
Every file, acknowledgement, correction and resubmission is archived with its history, ready for any inspection question.
- Submitted files and ACKs stored together
- Corrections and resubmissions linked
- Searchable by case, product, market or date
- Retention set to your policy
Four steps, one continuous flow
Validate
Schema and business rules
Route
Right agencies and partners
Transmit
Secure gateway submission
Track
ACKs, rejections and clocks
AI does the work. Your experts decide.
- Validating E2B (R3) files
- Routing by destination rules
- Transmitting through gateways
- Tracking acknowledgements
- Flagging rejections
- Monitoring every clock
in the
loop
- Final sign-off
- Resolving rejections
- Approving routing rule changes
- Managing partner agreements
- Late-submission decisions
- Inspection responses
vGenix Ai vs other approaches
How regulatory submission works today in most teams, with point tools, and with vGenix Ai.
| Area | Manual process | Point-tool automation | vGenix Ai |
|---|---|---|---|
| Validation | Errors found on rejection | Schema check only | Schema, ICH and regional rules checked before sending |
| Routing | Destinations decided by hand | Basic rules | Every authority and partner, by your rules |
| Transmission | Manual gateway uploads | Separate gateway tool | Integrated gateway submission |
| Acknowledgements | Checked in mailboxes | Partly tracked | Every ACK tracked; rejections flagged at once |
| Local requirements | Experts remember them | Hard-coded per tool | Configured per market and agreement |
| Clocks | Tracked in trackers | Partly tracked | Every case tracked against every clock |
| Archive | Files in folders | Tool-specific archives | Files, ACKs and corrections kept together |
“Point-tool automation” describes separate tools that each automate one step. It does not refer to any named vendor.
What changes, and how we measure it
Every engagement starts with your baseline. These are the measures we track for regulatory submission.
Illustrative scenario: a mid-size pharma company handling about 40,000 ICSRs a year across 3 regions. These figures are for discussion, not client results. In every engagement we agree baselines with you before go-live and measure results from platform data.
- First-pass acceptance rate
- On-time submission rate
- Time to resolve rejections
- ACKs tracked
- Late submissions
Part of one platform
Regulatory submission shares its data model, rules and audit trail with every other module, so nothing is re-keyed between them.
Intelligent safety should be one connected operation
Automate the work. Keep the decisions with your experts. Keep the evidence traceable. See it on your own data in six weeks.
6-week pilot on literature monitoring
- Baselines agreed up front
- Configured to your SOPs
- Measured on your own data
- Validation evidence from day one