The Compliance Landscape for the Pharmaceutical Industry is:
We understand that achieving and maintaining compliance in the pharmaceutical sector can be overwhelming and complex. The ever-changing regulatory environment demands constant vigilance, sharp acumen, and a forward-thinking approach.
Our team of dedicated healthcare compliance experts, armed with industry-specific knowledge and experience, is well-equipped to address the unique challenges faced by pharmaceutical companies today
We know how pharma works, and we know how to conduct business to ensure the requirements of the various laws and self-regulatory requirements across Europe are met including but not limited to ABAC, EFPIA, IFPMA and various country specific requirements. We eagerly look forward to collaborating with you to build a stronger, more compliant pharmaceutical industry
Services We Offer
At Eunomia Pharma Services, our team of compliance experts provides strategic guidance and operational support at both Europe and local country level.
Book a Consultation
FAQs
How do I set up a pharma compliance program?
Setting up a pharmaceutical compliance programme typically involves establishing governance structures, defining roles and responsibilities, developing policies and SOPs, implementing approval and monitoring processes, and delivering role-based training aligned with applicable legal and self-regulatory requirements such as the Association of the British Pharmaceutical Industry Code and the European Federation of Pharmaceutical Industries and Associations framework.
Eunomia Pharma Services supports organisations in designing practical compliance programmes tailored to their structure, risk profile, and geographic footprint.
How to build a healthcare compliance policy from scratch?
Building a healthcare compliance policy from scratch usually starts with identifying applicable legal and industry code requirements, defining governance expectations, and aligning procedures with how the organisation interacts with healthcare professionals and external stakeholders. Policies should be practical, role-relevant, and supported by training and monitoring processes.
Eunomia Pharma Services supports organisations in developing structured compliance policies aligned with operational workflows and regulatory expectations across markets.
Compliance gap analysis checklist for pharma company
A pharmaceutical compliance gap analysis typically reviews the structure and governance of policies and processes, including but not limited to HCP and HCO engagement processes, activity reviews, promotional and non-promotional material review, transparency disclosure, sample process, etc. It also involves review of governance systems, communications, training structure, monitoring framework, company culture, compliance maturity aligned with applicable legal and self regulatory frameworks.
Gap analyses usually involve document review, stakeholder interviews, benchmarking against industry standards, and risk mapping to identify areas of exposure. Findings are consolidated into a structured report with prioritised recommendations distinguishing immediate remediation actions from longer-term programme improvements.
Eunomia Pharma Services supports organisations through structured discovery, benchmarking, and risk-based gap assessments designed to strengthen healthcare compliance frameworks across markets.
How to fix compliance gaps before inspection?
Addressing compliance gaps before inspection usually involves performing root-cause analysis, updating policies and procedures, strengthening approval workflows and documentation practices, delivering targeted training, and implementing corrective and preventive action plans aligned with legal and self-regulatory expectations.
Eunomia Pharma Services supports organisations in prioritising remediation activities and strengthening compliance frameworks ahead of inspections or audits.
How to reduce the cost of non-compliance
Reducing the cost of non-compliance in pharmaceutical organisations typically involves strengthening governance structures, maintaining clear and practical SOPs, delivering role-based training, implementing effective approval workflows, and conducting regular monitoring and internal audits aligned with applicable legal and self-regulatory requirements, e.g., EFPIA, ABPI, GDPR, etc.
Eunomia Pharma Services supports organisations in identifying compliance risks early and implementing proportionate controls to prevent costly remediation actions and enforcement exposure.
What should be included in a pharma SOP?
A pharmaceutical SOP should clearly define the objective and scope of the process, roles and responsibilities, step-by-step process descriptions supported by a workflow diagram, approval and escalation pathways, documentation requirements, and links to applicable legal and self-regulatory requirements. It should also include supporting templates and auxiliary tools such as trackers, ensure appropriate version control, and be aligned with how activities are performed in practice.
Eunomia Pharma Services supports organisations in developing clear, practical SOPs that are easy to implement and aligned with governance expectations across markets.