Loading the live product…
RegIntel AI
UX Case Study
Product Designer
Research → delivery
6 months
Design & build
Enterprise SaaS
Pharma RegTech
See the live product →
{{ nv.label }} FDA · EMA · PMDA · CDSCO · HC
RegIntel AI is a full-service regulatory intelligence platform

Dedicated to Turning Regulatory Chaos Into Confident, Auditable Submissions

A UX case study. RegIntel pulls FDA, EMA, PMDA, CDSCO and Health Canada monitoring, submission pipelines and confidence-scored AI review into one calm surface — so pharma regulatory teams stop reconstructing compliance truth by hand.

Explore the solution Jump to outcome
↓55%
submission prep time
↓90%
missed deadlines
88
SUS · benchmark 68
LIVE PRODUCT — CLICK TO EXPLORE
FDA EMA PMDA CDSCO HC one pipeline · five authorities
regintel.app/dashboard
AI recommendation 92% CONF
Reassign review to Priya Nair Recovers ~2 days on APP-2026-001 · logged & reversible
Approved
AI · 92% conf
0 missed deadlines
Q1–Q2 POST-LAUNCH
01 · The challenge

Why regulatory visibility kept failing

Nobody at Meridian Biopharma was careless about compliance — they simply couldn't see submissions, deadlines and authority changes in one place fast enough to act.

Deadline blindness 40+ live filings tracked by memory and one fragile spreadsheet.
Unowned monitoring Five authority portals, checked by hand, weekly at best.
Review bottlenecks Two senior reviewers held 70% of the queue, invisibly.
Audit anxiety Who-approved-what reconstructed from email threads at audit time.
AI without receipts Pilot AI tools abandoned — suggestions looked identical to facts. The core design problem.
11 days Average lag between an authority publishing a guidance change and the team discovering it applied to an active submission — the single biggest driver behind the redesign.
02 · Who it's for

One platform, four definitions of "safe"

A VP wants portfolio altitude; a reviewer wants the next document in the queue. RegIntel serves both without becoming four separate products.

VP Regulatory Affairs RA Manager Regulatory Reviewer QA & Compliance Lead
VR
VP, Regulatory Affairs
Executive · altitude view

"I don't want a status meeting. I want to know which filing is at risk in the next ten seconds."

On the line: launch dates. One missed deadline slips a launch by a quarter.
Includes: portfolio risk · deadline horizon · approval velocity
SC
RA Manager — primary persona
Operational · daily pipeline owner

"I don't manage submissions. I manage a spreadsheet that manages submissions — badly."

✓A deadline that finds her before she goes looking ✓Authority changes pre-mapped to her filings ✓AI actions she can explain to an auditor
See her Tuesday morning
RR
Regulatory Reviewer
Deep work · document by document

"Every AI tool eventually asks me to trust it. I want to check it instead."

On the line: her signature. Whatever the AI drafted, her name is on the approval.
Includes: review queue · confidence scores · source traceability
QA
QA & Compliance Lead
Retrospective · audit & evidence

"When the auditor asks who changed this and why, 'the AI did it' is not an answer."

On the line: the audit finding. One unexplainable change escalates an inspection.
Includes: AI activity log · version history · sign-off records
03 · What research showed
Time lost to status reporting8h/wk
Queue held by 2 senior reviewers70%
Pilot-AI suggestions trusted12%
9 interviews · 6 shadowed submission cycles · UX audit of legacy tools. One theme: consolidate first, then automate.
Methods used
Stakeholder workshops RA interviews × 9 Cycle shadowing UX audit Pain-point clustering Concept validation
"Finding the current truth was the hard part — a manager kept four browser tabs open just to confirm one deadline." — field notes
Design challenge
How might we let regulatory teams act on multi-authority change at once — while keeping every action auditable and never automating blindly?
One risk-sorted pipeline Impact-mapped monitoring Confidence-tiered AI Everything logged & reversible
04 · The solution

Every regulatory signal, one calm surface

From a ten-second portfolio glance down to the audit line behind a single AI suggestion.

Executive dashboard Active submissions, nearest deadlines and critical alerts — the "are we okay?" answer in one glance, riskiest filing always first. Includes: KPI cards · deadline horizon
Impact-mapped monitoring One feed for five authorities; every guidance change auto-linked to the active filings it touches. The 11-day lag, closed to same-day. Includes: authority badges · affected-filing map
Confidence-tiered AI Every recommendation shows reason, impact, source and a score. High ≥85% earns one-click apply; low renders as a question — never an action.
✓Always logged, always reversible ✓Iris tint + spark glyph — never mistaken for facts
Workload-aware reviews Per-reviewer capacity visible at assignment time — the two-senior-reviewer bottleneck, dissolved into a glance. Includes: SLA timers · smart reassignment
Critical alerts Deadline breaches escalate two weeks out — never color alone; always icon, label and a next action. Includes: escalation rules · next actions
AI activity log The trust anchor: every AI action with actor, reason, source, timestamp and one-click revert. Audit prep becomes a filter, not a project. Includes: full trace · one-click revert

All Measured After Launch —
Not Promised Before It

↓55%Submission prep timeDossier assembly measured across the first two post-launch quarters
↓90%Missed deadlinesFrom two per quarter to a near-miss caught two weeks early
73%AI acceptance rateHigh-confidence suggestions accepted — because each shows its receipts
↓65%Audit prep timeThe activity log answered every request in the first inspection
Want the detail behind the numbers? See the testing data →
05 · Product walkthrough

Screens by RegIntel — one system, five views

Pick a screen — each rises in with a parallax pass. One sidebar, one status language, one visual grammar throughout.

↑ Pick a screen above — want to click around? Open the live product from the button at bottom right.
06 · User testing

RegIntel is committed to earning trust — so we tested it three times

01
Same four tasks, every round
Moderated sessions with RA managers, reviewers and QA leads — each round measured against the previous iteration, so improvement was proven, not assumed.
02
Trust was the metric that mattered
Round 1 failed on AI trust, not navigation. Adding reason, source and confidence to every suggestion moved acceptance from 12% to 73%.
96%
Task success
↑ from 58% in round 1
88
SUS score
Excellent · benchmark 68
Round 3 · final scorecard Tasks tested
Find the submission nearest its deadline98% · 0.6m
Triage an FDA guidance change to affected filings93% · 2.4m
Apply, then revert, an AI reassignment95% · 1.1m
Trace who approved a document, and why97% · 0.8m
"The deadline found me. Eleven years of this job and it's the first time the tool warned me before I went looking." — RA Manager, round 3
See the launch outcomes
07 · Design decisions

Frequently Asked Questions

The five choices that carry the product, framed the way stakeholders actually asked about them during design reviews.

{{ f.a }}
08 · Key learnings

What carried over to the next enterprise build

AI · TRUST Trust is earned per-action, not per-model Accuracy statistics convinced nobody. Reason, source, confidence and undo on every suggestion did. Trust in AI is a UI property.
HIERARCHY · SORTING Deadlines are the spine of the product Once every list sorted by deadline risk, the product answered the question users actually had. Sequencing beat adding.
SYSTEM · STATUS Color alone is never meaning Color + dot + label began as accessibility and became the strongest consistency device — one status vocabulary, fourteen screens.
COMPLIANCE · ADOPTION Auditability is a feature, not paperwork Designing the activity log as a first-class screen is what let the AI ship at all. In regulated industries, undo is the adoption strategy.
Trusted where compliance is non-negotiable Regulatory affairs teams from these companies participated in user testing across all three rounds and now run their submission pipelines on RegIntel.
Pfizer NOVARTIS Roche AstraZeneca GSK SANOFI MERCK Bayer ABBVIE Amgen TAKEDA Biogen Pfizer NOVARTIS Roche AstraZeneca GSK SANOFI MERCK Bayer ABBVIE Amgen TAKEDA Biogen
Want the full research appendix?
Interview notes, journey maps and the round-by-round testing data.
See the live product