Eunomia carries out commercial compliance audits and gap analyses for pharmaceutical and biotech companies in the UK. We test selected activities against the ABPI Code, anti-bribery expectations and your own procedures, and deliver risk-rated findings with a practical remediation roadmap and CAPA support.
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UK expertise · Practical delivery
For compliance leaders and leadership teams in pharmaceutical and biotech companies in the UK: a baseline audit for a growing company, a pre-inspection or pre-launch review, or independent testing after a complaint or Code ruling.
Policies can exist on paper while contracts, payments and approvals tell a different story. A useful audit tests whether the purpose was recorded, the right people reviewed the activity, the contract, payment and evidence agree, and exceptions were escalated.
From requirements to action
We agree the scope and sample, review documents, test selected activities end to end, interview process owners and walk through systems. Findings are risk-rated and linked to evidence, then turned into a remediation roadmap and CAPA with effectiveness checks.
We audit as practitioners who design and run these processes. Findings come with practical fixes, and we can support remediation through programme design, training and shared-service capacity if you need it.
What we can take on
What this gives you
Risk-rated findings linked to specific activities and evidence
A remediation roadmap with owners, dates and dependencies
Follow-up checks that show whether corrective actions worked
The rules in the UK
UK compliance audits are usually tested against the industry code, UK enforcement guidance and your own procedures. These are the main external references. Each summary links to its official source below.
Under paragraph 12.4 of the PMCPA Constitution and Procedure, where the Code of Practice Appeal Board rules that there is a breach of the Code, it may require an audit of the company’s procedures in relation to the Code, carried out by the Authority.
Explains how the UK Serious Fraud Office assesses whether a corporate compliance programme works in practice. It is enforcement guidance, not a pharmaceutical certification standard.
A commercial organisation assesses the nature and extent of its exposure to potential external and internal risks of bribery by persons associated with it. The guidance describes the assessment as periodic, informed and documented.
Related article
How gap analysis improves a healthcare compliance internal audit. Our article explains how to test selected activities, examine evidence and prioritise weaknesses rather than only confirm that policies exist, with findings connected to a risk, an owner and a follow-up check.
More reading: Compliance gap analysis · Audit readiness best practices · Pharma Compliance Readiness Checklist
This overview is informational and does not constitute legal advice. Scope and application should be confirmed for the organisation, activity and counterparty in question. Sources checked September 2026.
Questions, answered
Scope may include document review, operational testing, interviews, system walkthroughs, risk-rated findings and a practical remediation roadmap.
Yes. Under paragraph 12.4 of the PMCPA Constitution and Procedure, where the Code of Practice Appeal Board rules that there is a breach of the Code, it may require an audit of the company’s procedures in relation to the Code, carried out by the Authority.
Yes. Support can assess governance, procedures, approvals, training, HCP engagement, FMV, transparency, monitoring and certification against relevant expectations.
An audit validates past adherence by testing what happened. A gap analysis compares obligations with how the business operates now, to assess current effectiveness and future readiness. We often use both.
It identifies root causes, actions, accountable owners, due dates, dependencies and effectiveness checks, with progress tracked through governance.
No. Our audits cover commercial healthcare compliance, such as promotion, HCP engagement, anti-bribery and disclosure. They are not a substitute for a GxP inspection programme.
Yes. Within an agreed commercial compliance audit scope, we can test how an AI-supported workflow is governed, what data and outputs it uses, how approvals and human review work, whether changes are traceable, and how exceptions are monitored. Findings are validated against records and process evidence; AI output is not treated as audit evidence by itself.
Yes. Eunomia can structure and coordinate a defined commercial compliance project, such as a policy rollout, process redesign or remediation programme, with agreed deliverables, milestones, owners, dependencies, decision points and progress reporting. Project governance and client approval responsibilities are agreed at the outset.
Copy approval support can include workflow and SOP design, reviewer responsibilities, evidence and version control, approval records, certification steps where applicable, and monitoring of the process. Formal approval or certification remains with the company’s authorised personnel under the applicable code and local rules.
We will listen, ask a few questions and recommend the right scope—without obligation or pressure.
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