Regulatory Infrastructure That Thinks
Built to see, understand, and execute regulatory work — at scale.
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Our customers have saved thousands of hours with Regunaut
Regunaut Product Suit
Get to know Regunaut
Modular tools that execute regulatory work — and scale with your portfolio.
Fee Calculator
Accurate regulatory fee estimation — without spreadsheets.
Variation Classifier
Instantly understand what type of variation you’re dealing with.
Print Proofreader
Catch issues in regulatory prints before they become problems.
MAH Transfer Checklist
A clear, step-by-step view of what needs to be done — and when.
From Regulatory Tools to Regulatory Infrastructure
One system that connects markets, products and teams — and keeps regulatory work moving.
Everything is connected — even when your current tools aren’t. A single question, update, or decision can trigger fees, deadlines, risks, and actions across markets. Regunaut turns these signals into a connected system, so regulatory work keeps moving — without manual handoffs.
Don't just take our word for it
“I’d like to say 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. If you allow me, I’d like to share it with more colleagues in the regulatory field.”
RA Specialist, large EU pharma company
“Regunaut saves time on routine regulatory tasks and reduces a lot of manual effort.”
RA Specialist, large EU pharma company
“For a small regulatory team, tools like this make a real difference. We can handle more work without adding complexity.”
RA Specialist, large EU pharma company
New regulatory software shouldn’t take a year to implement.
Here’s what you can get done with Regunaut in the first 30 days.
For everyone who needs regulatory answers — without another email chain.
Built for teams who execute regulatory work.
Currently focused on medicinal product portfolios and European regulatory processes.
For Regulatory Affairs teams
For teams who handle variations, renewals and MAH transfers every day and need clear structure to execute regulatory work consistently across products and markets.
For Heads of Regulatory
For leaders who need visibility into what is happening across the portfolio, confidence in execution, and the ability to make decisions without constantly chasing updates.
For local and affiliate teams
For local teams who execute regulatory work within global frameworks and need clear tasks, timelines and country-specific guidance to stay aligned with HQ.
For business and management teams
For teams who need clear regulatory answers on timelines, approvals and costs — without starting another email chain or interrupting regulatory teams.
See how Regulatory work gets done - end to end.
