Cybersecurity · Risk · Compliance

Intelligence
for a Regulated
World.

MiTheon unifies cybersecurity, compliance, and risk intelligence for regulated organizations in pharma, biotech, and healthcare — turning complexity into clarity, confidence, and control.

Explore Services → Our Story
20%
CSV Cost
Reduction
30%
Faster GxP
Release Cycles
15+
Years ISRM
Leadership
Core Services
End-to-end ISRM for regulated industries.
01
CISO as a Service
Leadership, oversight, and strategic information security management.
02
Information Security Management System
Scalable ISMS aligned with ISO 27001, NIS2, NIST and industry standards.
03
CSV / CSA as a Service
Modern computer system assurance integrated with e-SDLC.
Basel, Switzerland · mitheon.ch
Regulatory Expertise
ISO 27001 NIS2 NIST CSF FDA 21 CFR Part 11 EU GMP Annex 11 SOX IT GDPR GAMP 5 COBIT ITIL
About MiTheon

Our Purpose

We turn the complexity of cybersecurity, risk, and compliance into clarity, confidence, and control — for the organizations that can't afford to get it wrong.

Organizations today face an environment that is more connected, more regulated, and more dynamic than ever. Cyber threats evolve at unprecedented speed, regulatory frameworks expand across industries and borders, and risk landscapes shift overnight. Navigating this is not just a technical challenge — it's a strategic one.

MiTheon exists to help organizations meet that challenge with intelligence, simplicity, and resilience.

"Behind every system, every process, and every regulation are people who rely on trust, safety, and reliability. We believe cybersecurity should protect not just data — but futures, reputations, and relationships."

MiTheon carries a deeply personal origin. The name blends Mitja and Theias — symbolizing the connection between generations and a commitment to building a safer digital world for those who follow.

Vision
To create a world where organizations operate with clarity, confidence, and resilience — no matter how complex or regulated their environment.
Mission
To empower organizations by turning cybersecurity, compliance, and risk management into a unified, intelligent experience — creating clarity today and resilience for tomorrow.
How We're Different
01
Clarity Through Intelligence
We eliminate noise. MiTheon delivers actionable understanding of threats, regulatory obligations, and risks — helping leaders decide with confidence.
02
Compliance Without Complexity
MiTheon automates, simplifies, and unifies compliance so organizations stay aligned with rules and standards across jurisdictions.
03
Human-Centered Design
Security tools should work for people. Every element of MiTheon is designed for usability, precision, and real-world workflows.
04
Prediction Over Reaction
We use intelligence to anticipate issues before they become problems — enabling proactive rather than reactive protection.
05
Built for Regulated Industries
Deep GxP, pharma, and biotech expertise. We speak your language — FDA, EMA, ISO 27001, NIS2, GDPR, SOX.
Services

End-to-End ISRM for Regulated Industries

Governance, risk management, security, and compliance services — designed for organizations where failure is not an option.

01 — CISO AS A SERVICE
🛡
CISO as a Service
Leadership, oversight, and strategic information security management tailored to regulated environments.
  • CISO guidance aligned to GxP & healthcare regulations
  • Cybersecurity strategy, governance & operating model
  • Executive reporting & steering committee leadership
  • Risk assessments: ISO 27001, NIST, NIS2
  • Vendor security assessments & due diligence
  • Security monitoring & SOC oversight
  • Incident response management
ISO 27001 NIS2 NIST GxP GDPR
02 — ISMS
🔒
Information Security Management System
Build, operate, and optimize a scalable ISMS aligned with ISO 27001, NIS2, NIST and industry best practices.
  • Establish & maintain ISRM governance framework
  • Security policies, processes & strategy development
  • Unified IT + Security + GxP risk register
  • Information Risk Management & ERM integration
  • Enterprise dashboards for board/leadership
  • Control maturity & vendor risk assessments
  • DLP & insider risk controls
GxP SOX GDPR ERM NIS2
03 — CSV / CSA
⚙️
CSV / CSA as a Service
Transformation of traditional CSV to modern CSA, integrated with e-SDLC for maximum efficiency and compliance.
  • Validation per FDA 21 CFR Part 11, GxP
  • CSV/CSA service management & resource allocation
  • Digital Quality & e-SDLC (Jira/xRay/Confluence)
  • Automated traceability & testing packages
  • IT Infrastructure Qualification
  • GAMP 5, EU Annex 11 compliance
  • Audit/inspection support & CAPA remediation
FDA 21 CFR Pt 11 GAMP5 e-SDLC Annex 11
Compliance Coverage

Specialized Regulatory Expertise

Deep expertise across the most demanding regulatory frameworks in healthcare and life science.

Information Security Governance
Establish and maintain an ISRM framework ensuring security strategies align with business objectives, GxP, SOX, GDPR, and NIS2.
  • GxP, SOX, GDPR understanding and integration
  • Security policies, processes and strategies
  • NIS2 governance structures and strategic priorities
Information Risk Management
Identify and manage information security risks with Enterprise Risk Management integration and continuous monitoring.
  • ISRM risk assessments
  • Control risk assessments
  • Vendor risk assessments
NIS2 Compliance Programme
End-to-end NIS2 implementation from gap assessment to verified compliance for essential and important entities.
  • Assessment against NIS2 requirements
  • Roadmap development and programme execution
  • Control implementation and external assessor support
SOX IT Controls
Implementing and maintaining SOX-relevant IT controls, supporting audit readiness and continuous compliance.
  • SOX control framework implementation
  • IT general controls (ITGC) design and testing
  • Remediation support for audit findings
CISO as a Service

Fractional Security Leadership

Strategic CISO capabilities without the overhead of a full-time hire — tailored for healthcare and life science environments where GxP and regulatory alignment are non-negotiable.

Core Security Leadership
  • CISO guidance aligned to healthcare & GxP regulations
  • Cybersecurity strategy, governance & operating model design
  • Executive reporting & steering committee leadership
  • Business Impact Assessments & security roadmap definition
Risk Management & Compliance
  • Enterprise & IT security risk assessments (ISO 27001, NIST, NIS2)
  • Third-party/vendor security assessments & due diligence
  • Computer System Validation (CSV) & data integrity support
  • Compliance with GAMP 5, 21 CFR Part 11, EU Annex 11
  • Audit/inspection support & CAPA remediation guidance
Operational Cybersecurity
  • Security monitoring & SOC oversight
  • Vulnerability management & secure configuration baselines
  • Incident response management
  • DLP implementation & insider risk controls
Policies, Awareness & Architecture
  • ISMS documentation (policies, SOPs, WI, guidelines)
  • Cybersecurity training & pharma/healthcare awareness
  • Business continuity & crisis communication support
  • Secure architecture reviews (cloud, OT, medical systems)
  • Identity & access management (IAM) modernization
Client References

Proven Impact in Regulated Environments

Delivering measurable outcomes in BioPharma and life science organizations across Europe.

CASE STUDY · BIOPHARMA
Strengthening Quality, Compliance & Risk Management in a BioPharma Environment
Challenge
  • Fragmented ISRM and CSV practices creating inconsistent control execution
  • Lack of unified governance reduced audit readiness and increased compliance exposure
  • Document-heavy SDLC slowed delivery and increased validation burden
  • Limited visibility into system risks hindered proactive quality oversight
Our Solution
  • Established central ISRM & CSV governance aligned with Quality expectations
  • Built harmonized IT Policy & Procedure framework, including AI governance
  • Integrated control matrix covering GxP, GDPR, security, regulatory requirements
  • Introduced digitalized eSDLC enabling traceability, automation, risk-based validation
20%
Cost Reduction
30%
Faster Cycles
131
Sites Covered
CSV / CSA Service Governance & Risk Process Governance Cyber Security
CASE STUDY · EU BIOPHARMA
ISRM & CSV Transformation — EU-Based BioPharma Organization
Challenge
  • Rapid organizational transformation with fragmented security & compliance practices
  • No unified ISRM or CSV governance model, inconsistent controls across IT and Quality
  • Inefficient, document-heavy SDLC slowing delivery and increasing validation effort
  • Limited visibility into system risks and compliance posture
Our Solution
  • Built a centralised ISRM & CSV organization with clear governance and operating model
  • Established modern IT Policy & Procedure framework, including AI governance
  • Shifted from document-based SDLC to digitalized eSDLC with automation and traceability
  • Assessed existing IT systems against new controls and defined risk-based mitigation plans
20%
CSV Savings
30%
Validation ↓
4 FTE
Embedded Team
CSV / CSA Service Governance & Risk Process Governance IT Infrastructure

Note: More company project references are available upon request.

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Company
MiTheon GmbH
Contact
Mitja Andlovec
Managing Director
Address
Klybeckstrasse 141
4057 Basel
Switzerland
Telephone
+41 (0)79 580 5324
Email
mitja.andlovec@mitheon.ch
accounting@mitheon.ch
Industry Focus
Pharmaceutical BioTechnology Healthcare Life Science