The Regunaut platform for regulatory affairs
Six tools for pharmaceutical regulatory teams, built around the work that fills a regulatory calendar: answering questions, pricing submissions, screening names, checking artwork and keeping a portfolio on track.
Who each tool is for
Regunaut is built for marketing authorisation holders managing medicinal product portfolios in Europe, from lean regulatory teams at generic manufacturers to regulatory leads responsible for dozens of licences across many markets. Each tool solves one task and shares the same product and market context.
Workbench is where regulatory specialists research a requirement, classify a variation or assess a new guideline, with answers that cite the authority source. Fee Calculation prices a submission per procedure, country and product before you commit to it. Name Checker screens candidate medicine names against the registers, trade marks, WHO INN stems and EEA languages before you file. Print ProofReader compares packaging artwork with the approved text, so wording changes are caught before print.
Atlas puts every licence, deadline and fee in the portfolio on one timeline, by product, market and owner, and prepares the work behind each item. Alerts watches the agencies and matches each update to the products and markets it affects. If you are planning around a specific workflow, the solutions for regulatory affairs and business development show how the tools combine.
Platform tools
Workbench
Research requirements, analyse documents and draft plans
ExploreAlerts
Preview regulatory updates by product and market
ExploreAtlas
Preview portfolio timelines, obligations and fees
ExploreFee Calculation
Authority fees, calculated per procedure, market & product
ExploreName Checker
Screen candidate medicine names against registers, marks, INN stems and languages
ExplorePrint ProofReader
Compare packaging artwork with approved text
ExploreCommon questions about the platform
Which procedures and markets does Regunaut cover?
National, decentralised, mutual recognition and centralised procedures across the 30 EU and EEA markets, with the MHRA, the FDA and the main agencies beyond Europe covered by Alerts. Workbench researches against EU and national sources; Fee Calculation prices submissions in every EU and EEA market.
Do the tools work on their own or only together?
Each tool does one job and can be used alone. Workbench, Fee Calculation, Name Checker and Print ProofReader are available on a free account. Atlas and Alerts hold your portfolio and the updates that affect it, and they share product and market data with the other tools, so an alert can open the work behind it in Workbench.
Where do the answers come from?
From the authority sources a regulator would cite: approval databases and product registers, legislation and guidelines, adverse event reports, clinical trial registers and HTA appraisals, queried live, plus the documents your team uploads. Every answer shows its sources so a specialist can verify it before using it.
Where does the platform run and who sees our documents?
In the Regunaut managed cloud or inside your own tenant, in your region. Models run inside that boundary and your documents are never used to train anyone's model.
How is it priced?
On credits, by suite and geography. A new account gets welcome credits to try the tools on real work; plans and top-ups follow for teams. Own-tenant deployment is priced separately.
Who is Regunaut for?
Marketing authorisation holders managing medicinal product portfolios in Europe: regulatory affairs specialists and heads of regulatory, local and affiliate teams, and the business development people who need regulatory answers to make commercial decisions.
Start with the task in front of you
Try Workbench, Fee Calculation, Name Checker and Print ProofReader for free, or book a walkthrough with the team.