Regulatory Affairs teams
Variations, renewals and MAH transfers, executed the same way 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.
Workbench prepares the regulatory work, Atlas holds the licences, and Alerts watches the authorities, all on the same product data. RA teams see what is due, learn what changed, and act on it without piecing the picture together from spreadsheets and inboxes.
Workbench
Cited answers to regulatory questions, from authority sources and your own documents.
Ask how to classify a variation, file a manufacturing change, or read a revised guideline against your plan. Workbench answers from EU, US and ICH sources and the documents you attach, asks when a missing detail would change the answer, and cites the passage behind every claim so your team can check it before acting.
Explore WorkbenchAsk Workbench your first regulatory question today.
The 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
Model layer · Your deployment
ClaudeGPTGeminiAny model
AI tools & agents
AgentsAlertsFee CalculatorRIM syncWorkbenchAtlasVariation ClassifiereCTD exportPrint ProofreaderMAH Checklists
The model is your choice, and so is where it runs: our cloud or your own tenant. Your documents are never used for training.
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.
04
Your deployment, your region
Run Regunaut in our managed cloud or your own tenant. Models run inside that boundary, and your documents never train anyone's model.
Trusted by leading pharmaceutical innovators
What regulatory teams say after using Regunaut
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.
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.
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
Regulatory infrastructure that speeds up the work, cuts manual effort, and lowers compliance risk.
Faster
24hFrom guidance published to portfolio impact mapped
- One environment for multi-market regulatory operations
- Multi-market registration strategy in hours, not weeks
- Decisions, citations, and precedent in one place
Cheaper
100+ hrsSaved per team / per month in manual review efforts
- Strategy work in-house, with fewer six-figure consulting engagements
- Manual work and rework, eliminated
- No rip-and-replace deployment. Runs alongside your existing stack
Lower Risk
39Authorities monitored across every product and market
- 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
New regulatory software shouldn't take a year to implement.
