01 / Frame
Context & appetite
- Risk policy & governance
- Risk appetite & tolerance
- Roles & accountability
ISO 31000
Risk and resilience built on recognised standards, from enterprise and quality risk management to business continuity and crisis response, so audits, disruption, and the unexpected find you prepared.
Governing standards
ISO 31000
Risk management · principles & guidelines
ISO 22301
Business continuity management systems
ICH Q9(R1)
Quality risk management (GxP)
ISO 14971
Medical device risk management
What we do
Resilience is not luck. It is the product of knowing what can go wrong, deciding what to do about it, and being ready before it happens.
We help organisations build risk and continuity capabilities on the standards their auditors, customers, and boards already recognise. The same discipline that satisfies an inspection also makes the business steadier and quicker to recover.
Whether you need a first risk framework, a quality risk file for a regulated product, or a continuity plan that has actually been tested, we provide practical, proportionate support across the full lifecycle.
The risk lifecycle
Framing, assessment, treatment, continuity, and crisis response, scaled to your exposure and the standards you are held to.
01 / Frame
ISO 31000
02 / Identify
ISO 31000 · ICH Q9
03 / Treat
ISO 31000
04 / Prepare
ISO 22301
05 / Respond
ISO 22361
Three disciplines, one standard of rigour
Risk shows up differently across the business: as strategy, as product quality, and as operational resilience. We work across all three, mapped to the controlling standard.
ISO 31000 · COSO ERM
A single, coherent view of risk across the organisation, built on ISO 31000 and aligned to the COSO enterprise risk management framework, so leadership can make risk-informed decisions and evidence them.
Design a proportionate risk-management framework: policy, governance, roles, and integration into how decisions are actually made.
Define and articulate risk appetite and tolerances that leadership can own and apply consistently.
Establish a living risk register with consistent scoring, analysis, evaluation, and clear treatment ownership.
Assess and monitor supplier, outsourcing, and supply-chain risk, with contractual allocation and ongoing oversight.
Risk reporting that gives the board and investors a clear, defensible picture, and stands up to audit.
Who we help
We scale support from a single risk assessment or continuity plan through to an integrated, standards-based risk and resilience programme.
01
Standing up a first risk framework and continuity capability as the business and its obligations grow.
02
Embedding ICH Q9 and ISO 14971 risk management that holds up in audits and inspections.
03
Hardening continuity, recovery, and crisis response where downtime carries real cost.
Practical · Proportionate · Defensible
We combine hands-on regulatory experience with recognised risk and continuity standards, so your programme is both certifiable on paper and effective when it is tested. Every recommendation is mapped to the controlling standard and sized to your exposure.
Every decision traced to the standard
ISO clause, ICH reference, or framework function: risk work with a source, not gut feel.
Sized to the risk
Rigour where exposure is real, and no bureaucracy where it is not. Risk management that gets used.
Built for the audit and the bad day
Evidence that satisfies an auditor, and plans that hold up when disruption actually hits.
Tell us what you need to protect, and we will help you build the risk and continuity capability to match.