Solutions · For Regulatory Affairs

Renewals, variations and PSURs, tracked for lean teams

Lifecycle maintenance is relentless. Every product carries renewals, variations and PSURs on their own clocks, in every market. Regunaut keeps all of it visible and moving: it surfaces what's due and drafts the work to clear it, so nothing lapses.

Lifecycle on autopilot

Every lifecycle clock, kept moving

Renewals + variations + PSURs
Upcoming worknext 60 days
14 days

Renewal

Atorvastatin

31 days

Variation

Metformin XR

48 days

PSUR

Salbutamol

Drafted next
Variation strategyReady
Fee estimateReady
Cover letterDrafting

Outcome

Every deadline cleared on time

Lifecycle work has different clocks. Regunaut surfaces what is due, prepares the repeatable pieces, and keeps each item moving before it is late.

The problem

Lifecycle work never stops, and one missed deadline is a compliance event

Renewals, variations and PSURs each run on their own cycle, per product and per market. Tracked in spreadsheets and memory, deadlines creep up and dependencies get lost, while the recurring grind eats the time a small team needs for everything else. Miss one item and a marketing authorisation is at risk.

How it works

Surface what's due, then clear it

1

Everything on one timeline

Atlas organises every renewal, variation and PSUR across the portfolio into a live timeline, so what's coming is always visible.

2

Triggers and changes folded in

Alerts feeds in regulatory changes that create new lifecycle work, so the plan stays current as the rules move.

3

Draft and submit faster

Workbench drafts the variation, renewal or PSUR groundwork from your own data, so each item is quicker to complete.

Workbench scenario

Clear the next lifecycle tasks before they become urgent

Workbench turns the lifecycle queue into drafted work your team can review and submit.

Workbench
+ New Task
Solution scenario/Lifecycle workboard

What lifecycle work is due in the next 60 days, and what can Workbench draft for the product owners now?

Regunaut
Regunaut12:39
35.05s8 sources94% confidence1 warning
1 warning

Executive summary

This is not one lifecycle queue; it is three different kinds of work. The renewal needs escalation today because the 14-day deadline is the only item that can become a compliance risk quickly.

The Type IB variation is ready for drafting now. Workbench has enough context to prepare the variation strategy, fee estimate and cover-letter skeleton so the owner starts from a reviewable package, not a blank document.

The PSUR should stay in monitor mode. It is not urgent yet, but keeping it visible prevents the team from rediscovering it when the deadline is suddenly uncomfortable.

Lifecycle workboard

Each recommendation carries its reasoning and a source trail, so the result can go straight to RA, BD or the product owner.

Work packets
Filter table...3 rows
ItemWorkbench readStatus
RenewalEscalate Atorvastatin renewal today; 14 days left.Needs review
VariationDraft Metformin XR Type IB strategy, fee estimate, and cover-letter skeleton.Check
PSURKeep Salbutamol visible; due in 48 days and currently on track.Ready
3 active itemsAtlas lifecycle timelineAlerts change feedFee rules
Why Regunaut

Compliance maintained, without the manual grind

Nothing lapses

Deadlines are surfaced early and tracked to completion, so no MA falls out of compliance.

Less repetitive work

Drafting and tracking are automated, which frees a lean team for the work that needs judgment.

One connected flow

Monitoring, portfolio, drafting and fees live in one place instead of four disconnected tools.

The whole lifecycle calendar, kept on track by the team you already have.

Put your lifecycle work on autopilot

See how Regunaut keeps renewals, variations and PSURs on track for lean teams.

Book a 30-min walkthrough