Fee Calculator
Determine exact agency fees for any submission type, automatically accounting for SME waivers, MAH locations, and currency conversions.
What are you calculating?Variation
Total fee29,087.61 €
Czechia23,974.80 €
Bulgaria5,112.81 €
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.
Atlas
Portfolio visibility for licences, obligations, fees, renewals, and lifecycle actions.
Atlas gives RA teams a structured view of medicinal product licences across products and markets, so upcoming deadlines, ownership, procedures, commitments, and actions are easier to see and manage.
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Atlas
Regulatory atlas
A portfolio command map for pipeline work, fees, renewals, agency deadlines, product lifecycle actions, and ownership.
May 21 – Jun 20, 2026
Atlas ItemStatus
T 21F 22S 23S 24M 25T 26W 27T 28F 29
PL/H/9999/001/DCDesloratadine - DCP procedure
On track
Preparation and submission
PL/H/9999/005/DCDesloratadine - DCP procedure
At risk
Preparation a...
PL/H/9999/002/DCDesloratadine - DCP procedure
Blocked
Res...
PL/H/9999/003/DCDesloratadine - DCP procedure
On track
Preparation and submis...
PL/H/9999/004/DCDesloratadine - DCP procedure
On track
Day ...
National (Poland)Desloratadine - PL procedure
Complete
IB S...
HU/666/01-04/QYHParacetamolum - HU procedure
On track
Review...
EMA/H/C/000214Tocilizumab BS - EMA centralised
At risk
Agency feedback
Window agenda
May 21 – Jun 20, 2026
14Items
5At risk
2Milestones
Needs attention6
Preparation and submissionPrep
PL/H/9999/001/DCPreparation and submissionRisk
PL/H/9999/005/DCResend agency questionsRisk
PL/H/9999/002/DCPreparation and submissionPrep
PL/H/9999/003/DCIB & II Variation submissionMilestone
HU/8888/002/DCReview questionsPrep
HU/666/01-04/QYHSelected item
HU/666/01-04/QYHParacetamolum - Blocked - Lead NT
Atlas
Regulatory atlas
A portfolio command map for pipeline work, fees, renewals, agency deadlines, product lifecycle actions, and ownership.
May 2026 – May 2027
| Product | EU (EMA) | UK (MHRA) | BR (ANVISA) | MX (COFEPRIS) | AR (ANMAT) |
|---|---|---|---|---|---|
Tocilizumab BS Biosimilar | $24,800next: 47d | $18,200next: 6 mo | $58,920next: 12d | $11,480next: 4 mo | — |
Paracetamolum Tablet | $14,400next: 9 mo | $11,200next: 64d | $6,680next: 5 mo | $3,980next: 7 mo | $1,140next: 8 mo |
Desloratadine Syrup | $16,400next: 22d | $9,200next: 11 mo | $5,680next: 8 mo | — | $1,140next: 6 mo |
Etanercept Biosimilar | $22,400next: 7 mo | $13,200next: 38d | $8,920next: 10 mo | $4,480next: 3 mo | — |
Adalimumab Injection | $12,400next: 5 mo | $9,200next: 7 mo | $5,680next: 4d | $2,980next: 11 mo | $1,140next: 9 mo |
Amoxicillin Capsule | $8,200next: 12 mo | $2,800next: 12 mo | $1,200next: 12 mo | $1,800next: 30d | — |
Ibuprofen Suspension | $6,400next: 6 mo | $3,100next: 60d | — | — | — |
Infliximab Biosimilar | $21,100next: 3 mo | $16,500next: 4 mo | $44,800next: 18d | $9,200next: 8 mo | — |
Financial overview
Yearly projection
$80,000Next 30 days
$262,820Total upcoming
Needs attention4
Tocilizumab BSHigh
BR (ANVISA) • $58,920next: 12d
DesloratadineHigh
EU (EMA) • $16,400next: 22d
InfliximabMedium
BR (ANVISA) • $44,800next: 18d
EtanerceptMedium
UK (MHRA) • $13,200next: 38d
Selected item
BR/ANVISA/2026/08Tocilizumab BS - $58,920 - Next: 12d
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.
01. Regunaut Product Suite (Tools)
Modular tools that execute direct regulatory calculations and classifications.
Variation Classifier
Classify post-approval changes (Type IA, IB, II, or national equivalents) and map the exact requirements and conditions needed for submission.
Change detected
Decision
Type II — C.I.b
Print Proofreader
Compare artwork PDF proofs against approved SmPC text. Automatically flags text deviations, missing warnings, and translation differences.
Issue detected
MAH Transfer Checklist
Build localized checklists for transferring ownership of Marketing Authorizations, tracking POA filings and representative requirements.
02. The Resources Database
Up-to-the-minute syncing and structure mapping global authority rules.
"Behind every view is the Resources Database. Every authority. Every fee schedule. Every guideline. We maintain them so your team doesn't have to. When ANVISA updates a fee on a Tuesday, our database is updated Tuesday. That's why 'exact amount' is a claim we can make."
Authority Database
Unified mappings across FDA, EMA, Health Canada, UK MHRA, Australian TGA, EUR-Lex, EudraLex, ANVISA, and European ministries—with hopes of adding many more.
Authority DatabaseSync Live
EMA ProfilesConnected
ANVISA ProfilesConnected
FDA ProfilesConnected
Live Fee Schedules
Track official fee schedule adjustments dynamically across 32 jurisdictions, preventing payment rejection and dossier submission delays.
ANVISA Fee SyncTuesday Sync
Schedule updateFee Table Rev. 3
Synced TuesdayVerification100% Accurate
Regulatory Guidelines
Continuously index official agency guidelines, Q&A papers, and procedural handbooks to ground AI reasoning in direct source truth.
Ingested Guidelines
EMA/CHMP GuidanceIngested yesterday
ICH Q3D(R2) GuidelinesIngested 3 days ago
Speed without losing traceability. Regunaut grounds AI-assisted work in authority sources, portfolio context, and citations, so teams move faster while keeping review in the loop.
25+ Feeds
Authority Sources
Official registers, agency portals, and national authority information used to structure medicinal product requirements.
32 Juris.
Fee Schedules
Agency fee rules, SME waivers, currency assumptions, and procedure-specific cost inputs.
84 Sources
Guidelines
Indexed regulatory guidance, procedural rules, Q&A documents, and authority instructions.
Grounded
Citation Engine
Outputs linked back to source documents, clauses, requirements, or portfolio context for review.
Tracking 250+ global sources across 32 jurisdictions.Hover components to explore →
Fee Calculator
Determine exact agency fees for any submission type, automatically accounting for SME waivers, MAH locations, and currency conversions.
Variation Classifier
Classify post-approval changes (Type IA, IB, II, or national equivalents) and map the exact requirements and conditions needed for submission.
Print Proofreader
Compare artwork PDF proofs against approved SmPC text. Automatically flags text deviations, missing warnings, and translation differences.
MAH Transfer Checklist
Build localized checklists for transferring ownership of Marketing Authorizations, tracking POA filings and representative requirements.
Authority Database
Unified mappings across FDA, EMA, Health Canada, UK MHRA, Australian TGA, EUR-Lex, EudraLex, ANVISA, and European ministries—with hopes of adding many more.
Live Fee Schedules
Track official fee schedule adjustments dynamically across 32 jurisdictions, preventing payment rejection and dossier submission delays.
Regulatory Guidelines
Continuously index official agency guidelines, Q&A papers, and procedural handbooks to ground AI reasoning in direct source truth.
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 authority update, fee change, variation, deadline, or agency question rarely stays isolated. Regunaut helps teams trace what it affects across products, licences, markets, owners, and next actions.
Trace what changes
Select a signal to see affected products, licences, markets, deadlines, risks, owners, and actions.
In medicinal product portfolios, one update can affect several markets, licences, fees, deadlines, and local actions. Regunaut connects these dependencies so teams can understand impact faster and move work forward without rebuilding the context manually.
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.
Regulatory Affairs teams
Variations, renewals and MAH transfers — executed consistently across products and markets.
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.
