Compliance Monitoring & Investigations
Continuous, ongoing observation and assessment of processes to detect deviations in real-time
Reviews the effectiveness of mitigation strategies implemented.
Continuously tracks identified risks using specific metrics and data.
Identifies changes in risk profile and triggers necessary adjustments.
May involve regular reporting and analysis of trend
Monitoring
Auditing
Verifies adherence to regulations, policies, and procedures after a certain period.
Monitoring
Continuous, ongoing observation and assessment of processes to detect deviations in real-time.
Auditing
Monitoring
Auditing
Monitoring
Auditing
Monitoring
Auditing
Involves interviews, document reviews, facility inspections, and formal reporting
Challenges
- Evolving Regulations
-
Lack Of Real Time Visibility Across Multiple
Jurisdictions - Unstructured Data And Data Overload
- Monitoring Third-party Compliance
- Fragmented Monitoring & Slices Compliance Function
- High Cost And Resource Constraint
- Accuracy And Integrity In Compliance Monitoring
Eunomia can support with
- Proactive Regulatory Intelligence
- Centralized Compliance Monitoring System
-
AI Driven Data Structuring &
Processing -
Rigorous Third-party Due
Diligence Framework - Integrated Compliance Framework and Cross Functional Collaboration
- Shared Service Model
- Unbiased Audit
Types Of Services
All the below-listed activities will be part of the Monitoring and Auditing services where Eunomia the end -to-end engagement.
Where needed, these services can also be offered as individual or a package of ad-hoc services.
Gap Analysis
Pre-Audit Readiness Check
Compliance Audits
Development of Centralized Risk Assessment Framework
Developing SharePoint (Intranet) structures for data collection and assessment
Data Analytics or Risk Identification and Prediction
FAQs
What monitoring services does Eunomia offer?
We offer risk-based compliance monitoring across promotional activities, external stakeholder interactions, events, third-party engagements, and internal processes. This includes remote and on-site reviews, documentation checks, and ongoing compliance health assessments.
What is your approach to investigations?
We conduct independent and objective investigations into potential compliance breaches or internal concerns—following structured protocols that include fact-finding, stakeholder interviews, evidence review, root cause analysis, and documentation of findings.
Can you help us design a monitoring plan or calendar?
Yes. We work with your compliance and business teams to design a risk-based annual monitoring plan or ad hoc activity-specific monitoring schedule—tailored to geographies, functions, and areas of concern.
Do you provide monitoring checklists or tools?
Absolutely. We develop customized monitoring templates, checklists, evidence logs, and scorecards to ensure consistency and audit readiness across your internal or outsourced monitoring programs.
Can you support monitoring of field force activities and speaker programs?
Yes. We routinely monitor field interactions (e.g., ride-alongs, call notes, sampling) and speaker programs to ensure adherence to promotional codes, script compliance, fair market value, and documentation standards.
Do you assist with post-monitoring remediation and CAPA?
Yes. We don’t stop at reporting findings—we also support development and tracking of Corrective and Preventive Actions (CAPAs), policy updates, and training interventions to close identified gaps.
How do you maintain confidentiality during investigations?
All investigations are conducted with strict confidentiality, professionalism, and neutrality. We use a predefined scope and access control protocol to protect whistleblowers, sensitive information, and the integrity of the process.
Can Eunomia support investigations initiated from speak-up channels?
Yes. We manage end-to-end investigations stemming from internal speak-up or whistleblowing systems—triaging cases, collecting evidence, conducting interviews, and preparing defensible reports for internal and regulatory use.
Are your services compliant with global and local standards?
Yes. Our monitoring and investigations services are aligned with global regulations and industry codes such as EFPIA, ABPI, FCPA, UK Bribery Act, and local data protection laws including GDPR.
How can we engage Eunomia for monitoring or investigations?
Simply contact us via our Contact Page or email hello@eunomiapharmaservices.com. We’ll set up an initial call to understand your priorities and propose a practical, risk-aligned approach.