Minosia
Minosia (DBA Regnora) is a Sweden-based provider of an agentic AI compliance platform that automates regulatory gap analysis, document generation, and recurring compliance workflows for QA, RA, and compliance professionals in MedTech, BioTech, Pharma, and Cybersecurity firms across Europe.
- Company typePrivate
- Founded-
- Headquarters—
- Headcount1–10
- GTM typeB2B
- OfferingSoftware
What Minosia does
Minosia, operating commercially as Regnora, is a Sweden-based provider of an agentic AI compliance platform targeted at quality assurance, regulatory affairs, and compliance professionals in life-sciences and adjacent regulated industries. The platform connects to existing document repositories — OneDrive, SharePoint, Google Drive, or any eDMS/eQMS — without requiring data migration, and deploys a multi-agent system that performs gap analyses against frameworks such as MDR, IVDR, ISO 13485, IEC 62304, ISO 14971, ISO 27001, EU AI Act, and GxP, generates or revises controlled documentation, and answers natural-language questions with cross-document citations. A Compound Learning layer captures customer-specific templates, skills, rules, and memory to reduce rework over time, and trigger-based Custom Agents automate recurring compliance work such as calendar updates, framework reviews, and change-control drafting.
The platform is positioned for enterprise-grade auditability: it is built to GAMP 5, ISO 80002, and EU AI Act requirements, with validation tools for custom agents and full audit logging; all data is held in the EU with no training on customer content. The commercial model is a credit-based subscription with self-serve tiers (Basic €99/month, Pro €249/month, Max €499/month) aimed at SMB and mid-market teams, plus an Enterprise tier with custom pricing, on-premise deployment, SSO, and dedicated onboarding. Go-to-market combines product-led growth via direct website signup with a field-sales motion for larger customers.
Minosia is a private, pre-seed/seed-stage company. The firmographic data indicates 1–10 employees, a small named leadership team (CEO David Buresund, CTO Thony Price, Senior Compliance Expert Anna Annerberg, Senior Advisor Christina Lidén), a single disclosed funding round of approximately $155,252 from Antler in December 2024, and no disclosed revenue, customer logos, or institutional investors beyond Antler. The company is actively operating and selling, with the Regnora platform publicly launched and priced, but financial scale and customer concentration remain undisclosed.
Minosia firmographics
Firmographics- Name
- Minosia
- Website
- https://minosia.com
- Company type
- Private
- Operating status
- Operating
- Headcount range
- 1–10 employees
- Short description
- Minosia (DBA Regnora) is a Sweden-based provider of an agentic AI compliance platform that automates regulatory gap analysis, document generation, and recurring compliance workflows for QA, RA, and compliance professionals in MedTech, BioTech, Pharma, and Cybersecurity firms across Europe.
- Ownership category
- akta.pro rank
Minosia industry classification
Industry- Product category
- Regulatory Compliance Software
- NAICS
- Computer Systems Design and Related Services (5415)
- SIC
- Services-Prepackaged Software (7372)
- akta.pro primary industry
- Model Governance, Risk & Compliance (GRC) Platforms (HDAAAKAA)
- akta.pro secondary industries
- Responsible AI, Security & Privacy Platforms (Safety, Guardrails, PII) (HDAEANAG), Audit, Explainability & Accountability Tooling (traceability, reporting) (HDAAAKAL), Responsible AI, AI Governance & Compliance Services (BPAEAHAJ)
Keywords
Minosia business model
Business model- GTM type
- B2B
- Offering type
- Software
- Cost components
- Technology or R&D, Personnel, Operations, Marketing or Sales, Infrastructure
Revenue model
- Subscription - Credit-Based Plans: Monthly subscription plans (Basic €99, Pro €249, Max €499) with allocated credits for usage. Credits consumed for gap analyses, document generation, and custom agent runs. Enterprise tier with custom credit volume and bespoke contract terms.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Subscription | Monthly | Basic - €99/month for 5,000 credits, small firms 1-3 users |
| Subscription | Monthly | Pro - €249/month for 15,000 credits, mid-market teams 5-15 users |
| Subscription | Monthly | Max - €499/month for 35,000 credits, teams with heavy multi-agent workloads |
| Subscription | Multi-year contract | Enterprise - Custom pricing for larger firms with bespoke compliance needs |
Go-to-market motion2 records
Distribution channels2 records
Marketing channels1 record
Minosia product offering
Product offeringCore offering
Minosia operates the Regnora platform, an agentic AI compliance automation system for life-science companies (MedTech, BioTech, Pharma, Cybersecurity). The platform connects to existing document repositories (OneDrive, SharePoint, Google Drive, eDMS/eQMS) and runs AI-powered gap analyses against regulatory frameworks (MDR, IVDR, ISO 13485, IEC 62304, ISO 14971, ISO 27001, EU AI Act, GxP), generates or revises controlled documents, answers compliance questions with cross-document citations, and automates recurring compliance work through trigger-based custom agents.
Product overview
Regnora is a unified agentic compliance platform designed for QA, RA, and compliance consultants in life-science industries. The platform consists of a single integrated system with multiple functional modules: Gap Analysis (automated compliance gap detection against regulatory frameworks), Revise (AI-powered document generation and updates), Discover (natural language Q&A across management system documentation), Custom Agents (trigger-based automation for compliance workflows), and Compound (template/skill/rule reuse system that improves with usage). The platform integrates with existing document storage systems (OneDrive, SharePoint, Google Drive, eDMS/eQMS) without requiring data migration, with all documents remaining in their original locations.
Differentiator
Problem solved
Functional benefit
Products and services
- Regnora Platform
Quantifiable outcome
- < 4 hours for MDR gap analysis vs weeks manual
- +4 more outcomes
Companies that use Minosia
Customer profileSegments3 records
Ideal customer profiles3 records
Minosia technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Integration4 records
AI capability6 records
Feature7 records
Minosia partnerships and signals
Strategic signalScale indicators5 records
Recent moves5 records
Expansion highlights5 records
Minosia competitors and assessment
Company assessmentBroad incumbents
- Veeva Systems (Veeva Vault): Dominant cloud platform provider for life sciences, including Veeva Vault Quality and Regulatory Information Management. Serves the same MedTech/pharma compliance customer base and represents the most formidable incumbent competitor for AI-native compliance entrants.
- MasterControl: Established enterprise QMS / quality and compliance suite spanning life sciences and other regulated industries. A long-standing incumbent in MedTech document control and audit management whose roadmap includes AI-enabled compliance features.
Emerging players
- ComplianceQuest: Cloud-native QMS and compliance platform built on Salesforce, with AI features spanning document management and audit workflows. Partial overlap with Regnora's regulated-industry customer base.
- Credo AI: AI governance, risk and compliance platform for enterprise AI systems (model risk, EU AI Act readiness, audit). Adjacent to Regnora's 'responsible AI / governance' coding, but framed around AI systems rather than life-sciences documentation.
- Holistic AI: AI governance, risk and compliance platform with EU AI Act–aligned tooling. Overlaps thematically with Regnora's responsible-AI / EU AI Act positioning even though it targets AI/ML model risk rather than life-sciences documentation.
- Monitaur: AI governance and audit platform (model monitoring, documentation, compliance) for regulated enterprises. Comparable on the AI governance / audit-trail axis that Regnora uses for EU AI Act and GAMP 5 support.
Direct peers
- Qualio: Cloud QMS for life sciences covering document control, training, audits and supplier management. Overlaps directly with Regnora's MedTech/BioTech/Pharma compliance gap-analysis and document generation use cases.
- Greenlight Guru: MedTech-specific QMS and compliance platform offering document control, design controls, and audit readiness for the same QA/RA buyer persona Regnora targets. Both sell software-with-services for life-sciences compliance across MDR/ISO 13485.
- Dot Compliance: eQMS and AI-enabled compliance automation for life sciences, including gap analysis, document generation and audit prep. Targets the same regulated QA/RA personas and competes head-to-head on the medtech compliance workflow.
- ArisGlobal: Life sciences R&D and compliance suite (Regulatory, Safety, Quality). Sells to similar pharma/MedTech QA and regulatory stakeholders and is increasingly layering AI into regulatory document and submission workflows.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat5 records
Key risks7 records
Key highlights7 records
Customer concentration
Minosia compliance and trust
Trust signalCompliance4 records
Minosia financial estimates
Financial estimateRevenue estimate
Valuation estimate
Minosia leadership team
Management profileNumber of profiles
Profiles4 records
Minosia funding detail
Funding detailFunding overview
Funding rounds1 record
Investors1 record
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Minosia M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about Minosia
What does Minosia do?
Minosia operates the Regnora platform, an agentic AI compliance automation system for life-science companies (MedTech, BioTech, Pharma, Cybersecurity). The platform connects to existing document repositories (OneDrive, SharePoint, Google Drive, eDMS/eQMS) and runs AI-powered gap analyses against regulatory frameworks (MDR, IVDR, ISO 13485, IEC 62304, ISO 14971, ISO 27001, EU AI Act, GxP), generates or revises controlled documents, answers compliance questions with cross-document citations, and automates recurring compliance work through trigger-based custom agents.
Is Minosia a public or private company?
Minosia is a private company. It is classified as venture growth investor backed and is currently operating.
When was Minosia founded?
Minosia was founded in -1. It employs 1 to 10 people.
How does Minosia make money?
One revenue line is on record: subscription - Credit-Based Plans.
Who are Minosia's main competitors?
Broad incumbents on record are Veeva Systems (Veeva Vault) and MasterControl. Emerging players are ComplianceQuest, Credo AI, Holistic AI and Monitaur. Direct peers are Qualio, Greenlight Guru, Dot Compliance and ArisGlobal.
Does Minosia have an API?
No public API is recorded for Minosia.
What industry is Minosia in?
Minosia's product category is Regulatory Compliance Software. Its primary akta.pro industry code is HDAAAKAA, Model Governance, Risk & Compliance (GRC) Platforms, with a secondary code of HDAEANAG, Responsible AI, Security & Privacy Platforms (Safety, Guardrails, PII). Its NAICS code is 5415 and its SIC code is 7372.