Regulatory Affairs teams
Variations, renewals and MAH transfers — executed consistently across products and markets.
More regulatory capacity for portfolios that keep growing
Manage licences, renewals, variations, and fees across your whole portfolio, without scattered spreadsheets, inboxes, or expert memory.
Grounded in real authority requirements for medicinal products.
Why Large Licence Portfolios Become Hard to Manage
Broad medicinal product portfolios create hundreds of regulatory actions across licences, markets, fees, renewals, variations, and commitments. The work becomes hard to manage when the context is scattered and the people who know it are already overloaded.
Scattered Licence Knowledge
5–8 placeswhere licence history usually lives
RIM, spreadsheets, authority correspondence, shared drives, local trackers, legacy submissions, email threads, and expert memory.
Manual Checks
30–60 minfor one “quick” regulatory question
Time disappears into finding the right source, confirming what is current, checking market applicability, and preparing the next action.
Limited Workload Visibility
100s–1000sof open regulatory actions
Variations, renewals, fees, labelling updates, commitments, supply changes, and local implementation steps.
Hard-to-Replace Expertise
1–3 peopleoften hold the real operating context
Critical context often sits with a few senior RA professionals. Efficient, until it very suddenly is not.
The Root Cause
Regulatory workload grows faster than regulatory capacity
The pattern is usually driven by three pressures that grow quietly across mature medicinal product portfolios.
01
Portfolio Volume
More products, licences, markets, renewals, variations, fees, and post-approval commitments.
02
Fragmentation
The context needed to act is spread across systems, documents, trackers, inboxes, affiliates, and people.
03
Talent constraint
Experienced RA professionals are difficult to hire, expensive to replace, and too often used as human search engines.
The Platform
See the portfolio. Monitor change. Execute the work.
Regunaut connects medicinal product licence data, authority monitoring, and regulatory execution in one structured layer, so RA teams can see what matters, monitor what changes, and act with less manual coordination.
Workbench
AI workspace for complex regulatory projects and strategy.
Workbench works alongside RA teams to analyse requirements, build plans, draft structured outputs, and move complex regulatory work faster. It traces relevant licence context, authority requirements, source documents, and prior decisions, so outputs remain reviewable and grounded.
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Workbench
Projects/Quick Tasks
I'm your regulatory research collaborator—built to reason, analyze, and iterate alongside you.
What regulatory task can I help you with today?
@ ResourceWorkflow
Structured data submission readiness
Analyze regulatory developments for structured data submissions...
Generic product registration plan
Determine the registration pathway and prepare a submission pla...
Renewal readiness checklist
Create a renewal readiness checklist for products authorized via...
Authority clarification response
Draft a structured response to authority clarification questions...
15-minute live walkthrough of Atlas, Alerts, and Workbench
Book a live demoThe Trust Layer
Regulatory AI your team can actually review
Regunaut grounds AI-assisted work in authority requirements, fee schedules, guidelines, product context, and source documents, so outputs can be checked, cited, challenged, and refined by regulatory teams.
Regulatory sources
25+ authority sources84 guideline sourcesFee schedules · 32 jurisdictionsFilings & source documentsYour product portfolio
AI tools & agents
AgentsClaudeFee CalculatorRIM syncWorkbenchOpenAIVariation ClassifiereCTD exportPrint ProofreaderMAH Checklists
01
Grounded citations
Every output links back to the clause, guideline, or source document it came from.
02
Same-day sync
When an authority updates a fee or guideline, the database reflects it the same day.
03
Review in the loop
Outputs are built to be checked, challenged, and refined by your regulatory team.
Don't just take our word for it
I've had the opportunity to test your new platform and I really like it. The idea is excellent, the platform is intuitive and above all very useful. I'd like to share it with more colleagues in the regulatory field.
Regunaut saves time on routine regulatory tasks and reduces a lot of manual effort.
For a small regulatory team, tools like this make a real difference. We can handle more work without adding complexity.
Trusted by leading pharmaceutical innovators
See what Regunaut can do for your team.
Regulatory work is connected.
Your tools should be too.
A new regulation, guideline update, or agency question never stays isolated — it moves licences, procedures, fees, deadlines, and priorities. Regunaut keeps the whole chain connected.
Trace what changes
Select a signal to see affected products, licences, markets, deadlines, risks, owners, and actions.
Select any node to trace what it triggers downstream. In a live portfolio, Regunaut runs this same dependency graph across every product, licence, and market you manage.
Here's what you can get done with Regunaut in the first 30 days
New regulatory software shouldn't take a year to implement.
Built for teams who execute regulatory work
Currently focused on medicinal product portfolios and European regulatory processes.
Heads of Regulatory
Portfolio-wide visibility and confidence in execution, without chasing updates.
Local & affiliate teams
Country-specific tasks and timelines, aligned with global frameworks and HQ.
Business & management
Clear timelines, approvals and costs — without another email chain.
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TimelineCostStatus
Business Value
Three Ways Regunaut Pays Off
Smarter regulatory infrastructure designed to deliver immediate velocity, efficiency, and safety.
Faster
- One environment for multi-market regulatory operations
- Multi-market registration strategy in hours, not weeks
- Decisions, citations, and precedent in one place
24hFrom guidance published to portfolio impact mapped
Cheaper
- Strategy work in-house - fewer six-figure consulting engagements
- Manual work and rework, eliminated
- No rip-and-replace deployment - runs alongside your existing stack
100+ hrsSaved per team / per month in manual review efforts
Lower Risk
- Surfaces relevant authority decisions before they land
- Flags risk across your portfolio in real time
- Every output cited, traceable, audit-ready
- GxP aligned with 21 CFR Part 11 audit logging built in
- ISO 27001 and SOC 2 Type II implementation underway
40+Authorities monitored across every product and market
See how Regulatory work gets done - end to end.
