Why Risk Assessment Matters in Healthcare Compliance
Regulatory scrutiny is intensifying, data volumes are rising, and healthcare operations are becoming more complex. Risk assessment is no longer optional—it's essential for:
- Ensuring compliance with ABPI, EFPIA, FCPA, GDPR, and other local/global standards
- Protecting patient safety and product integrity
- Safeguarding reputation, finances, and operations
- Empowering proactive, data-driven decision-making
Our Risk Assessment Framework
Eunomia helps you move from reactive compliance to proactive governance through our structured and scalable risk management approach:
Risk Identification
We analyze your operations, third-party relationships, promotional activities, and internal processes to identify exposure points.
Risk Assessment
Using defined scoring models, we assess the likelihood and impact of each risk—tailored to your business model and market environment.
Risk Response
We recommend mitigation strategies, define control points, and create targeted action plans supported by SOPs and accountability maps.
Risk Monitoring
We help you track risks over time through dashboards, review cycles, and internal triggers that flag evolving compliance concerns.
Risk Reporting & Evaluation
We generate management-ready summaries, risk heatmaps, and audit-proof documentation to support internal reviews and external inspections.
Challenges We Help You Overcome
| Challenge | Eunomia Solution |
| Local compliance complexity | Risk tools and methodologies localized to country-specific regulations |
| Siloed risk visibility | Centralized risk dashboards and reporting structures |
| Lack of actionable insights | Data-driven scoring, heatmaps, and prioritized mitigation plans |
Our Capabilities
Why Choose Eunomia?
- Global Perspective, Local Precision: From EU and UK frameworks to market-specific nuances, our team understands risk across borders.
- Deep Compliance Integration: Risk frameworks grounded in EFPIA, ABPI, IFPMA, GDPR, FCPA, and national codes.
- Not Just Advice—Real Implementation: We don’t just assess risks; we build the workflows, SOPs, and governance layers to manage them.
- Technology-Agnostic Support: We work within your existing systems or build light tools on platforms like SharePoint.
FAQs
What types of risk assessments do you offer?
We offer comprehensive compliance risk assessments across various domains—HCP engagement, third-party management, promotional activities, data privacy, speak-up systems, and policy adherence. Our assessments cover both proactive (preventive) and reactive (incident-driven) approaches.
Do you follow a specific methodology for compliance risk assessments?
Yes. We use a structured, defensible methodology that includes risk identification, classification (e.g., likelihood and impact scoring), prioritization, and mitigation planning. Our approach is informed by global best practices and tailored to your internal governance framework.
Can you help us design a custom risk assessment framework?
Absolutely. We build tailored risk assessment frameworks that align with your organizational structure, compliance maturity, regulatory footprint, and internal risk appetite—whether you’re a startup, mid-size biotech, or global pharma company.
Do you offer tools or templates for internal use?
Yes. We provide risk heatmaps, scoring templates, interview guides, and SharePoint-based tools to streamline data collection, scoring, and documentation. We can also train your teams to use these tools independently.
Can you facilitate live risk assessment workshops with our teams?
Yes. We conduct interactive workshops—onsite or virtual—with key internal stakeholders to gather insights, map current processes, and assess inherent and residual risks across business functions.
How often should we conduct compliance risk assessments?
We recommend conducting a baseline risk assessment annually and updating it during major business changes (e.g., launch planning, new partnerships, mergers). We can also set up a cadence for ongoing monitoring or quarterly refresh cycles.
Do you support country-specific or function-specific assessments?
Yes. We offer targeted assessments for individual markets, departments (e.g., Medical, Commercial, Regulatory), or processes (e.g., advisory boards, grants, patient support programs) based on risk exposure and local regulatory obligations.
Can you help us convert risk assessment findings into action plans?
Definitely. We not only identify risks but also help develop practical mitigation strategies, internal controls, CAPA plans, and responsibility matrices to drive accountability and reduce exposure.
How do you ensure regulatory alignment in your risk assessments?
Our assessments are aligned with relevant global and local frameworks such as EFPIA, ABPI, FCPA, UK Bribery Act, EU GDPR, and IFPMA codes. We also stay up to date with guidance issued by enforcement bodies and industry associations.
How can we engage Eunomia for a risk assessment?
Reach out through our Contact Page or email us at hello@eunomiapharmaservices.com. We'll conduct an initial discussion to understand your current state and design a risk assessment strategy that fits your objectives and timeline.