Leadership · Vigilance services · Audit & advisory
YMUNIT supports regulated organisations and critical environments by leading IT, cybersecurity and AI functions and programmes, strengthening vigilance systems, and independently auditing risks, systems and obligations.
References and operating environments
YMUNIT works with organisations across healthcare, industry, infrastructure, technology and regulated services.
Three pillars
Lead a function or programme, secure your vigilance systems, or audit your risks: choose the service that matches your priority.
Leadership & programmes
YMUNIT assumes responsibility for a function, programme or transformation to restore control, deliver results and build a sustainable organisation.
Vigilance services
Pharmacovigilance, medical-device vigilance, cosmetovigilance, computerised systems, outsourcing and inspection readiness.
Audit & advisory
Cybersecurity, IT, OT, quality, compliance, AI, supplier and critical-system audits.
When to engage us
Vacant CIO, CISO, audit or compliance leadership: regain control without delay.
A fragile schedule, multiple dependencies or governance that needs to be restored.
Pharmacovigilance, medical-device vigilance or cosmetovigilance to structure or regain control of.
Prepare the evidence, teams and inspection room before the event.
Validation, data migration or maintenance of the validated state.
Due diligence, supplier audit and dependency control.
Why YMUNIT
Experts able to assume genuine accountability, make decisions and act in complex situations.
An integrated view of operations, systems, risks and applicable obligations.
Engagements designed for sensitive environments, audits and high-stakes programmes.
Decisions, roadmaps, reports and evidence that executives, teams and auditors can use immediately.
Documentation, training and knowledge transfer are built into our engagements to prepare autonomy and continuity.
Concrete evidence
Insufficient governance, a fragile schedule, multiple dependencies or providers that are difficult to coordinate.
Governance reset, risk control, executive arbitration and programme leadership.
A clarified trajectory, defined accountability and programme control restored.
An incomplete organisation, an overstretched function, a system to take over or an inspection to prepare for.
Assessment, operating-model design, leadership, computerised systems and evidence preparation.
A documented, controlled system capable of demonstrating compliance.
Poorly evidenced risks, dispersed findings or insufficient executive visibility.
Independent assessment, prioritisation of findings and development of a roadmap.
Faster decisions and an immediately actionable plan.
Experience of YMUNIT leaders and experts
19+ years
of operational experience across pharma, industry and IT
10,000+
projects, audits, controls and transformation activities in sensitive environments
Programmes
worth several billion euros
led throughout our experts’ careers
Up to 200+
contributors coordinated across complex programmes
Frequently asked questions
When a critical function has no accountable leader, an IT, cybersecurity or AI programme is in difficulty, or a transformation must be led without delay. YMUNIT assumes responsibility, restores control and prepares a sustainable handover. View Leadership & programmes.
Yes. We lead end-to-end AI programmes: strategy and use-case portfolio, data and model governance (AI Act, ISO 42001), industrialisation of proofs of concept and business adoption. Independent assurance of an AI system is covered under Audit & advisory.
Pharmacovigilance, medical-device vigilance and cosmetovigilance: system design and implementation, outsourced QPPV or function, case and signal management, periodic reports, provider oversight and inspection readiness. View Vigilance services.
Yes: scoping and selection, validation (CSV/CSA, GAMP 5, Annex 11 and 21 CFR Part 11 as applicable), data migration, maintenance of the validated state and audit. YMUNIT is not a safety-database vendor: we secure your systems independently.
Cybersecurity, IT and OT audits (ISO 27001, NIS2, DORA, HDS, IEC 62443), quality and compliance, risk and supplier governance, and AI-system assurance. Every engagement produces prioritised findings and defensible evidence. View Audit & advisory.
With a confidential, no-commitment initial discussion. We scope the requirement, identify the appropriate engagement model (targeted support, outsourced function, audit or Build–Operate–Transfer) and reply within two business days.
Contact
Describe your situation. We will reply within two business days to frame the requirement and identify the appropriate engagement model.
