Audits and Inspections

Audit readiness is the state of being continuously prepared for compliance reviews or inspections, internal or external, at any time. It goes beyond one-off preparation and embeds documentation quality, controls, evidence trails, and governance into everyday operations, so audits become systematic validations of work already done rather than stressful, last-minute exercises.

A compliance gap analysis is a structured assessment that compares your current compliance framework against regulatory requirements, industry codes, and best practices. It identifies areas of non-alignment, procedural gaps, documentation weaknesses, or training shortfalls so you can prioritise remediation before an audit or inspection.

Yes. We conduct mock audits and simulated inspections tailored to your organisational risk profile and applicable inspection standards. These exercises recreate the audit experience, reviewing documentation, interviewing stakeholders, and testing processes, to uncover gaps early and improve confidence ahead of real regulatory or internal reviews.

Yes. Our audits are designed to assess compliance with both regulatory requirements and industry-specific standards, including frameworks such as the Charte de la Médicale in France that govern interactions with healthcare professionals, ethical conduct, and transparency expectations, ensuring your documentation, processes, and controls reflect local and code-specific obligations.

A comprehensive audit typically includes, Review of policies, SOPs, and governance documentation, Evaluation of process execution and controls, Assessment of training, record-keeping, and documentation quality, Interviews with key stakeholders, Identification of non-conformities and risk areas, Clear audit reporting with findings and recommendations.

These elements create a defensible audit outcome and support continuous compliance.

Following an audit or gap assessment, we assign risk ratings and priority levels to each finding based on regulatory impact, likelihood, and potential exposure. We then develop a clear, risk-based remediation roadmap, including defined corrective and preventive actions (CAPAs), ownership, timelines, and dependencies.

We work closely with your teams to implement updates to processes, SOPs, training, and controls, and track CAPA progress and effectiveness over time. This ensures findings are not only addressed but sustainably embedded into your ongoing compliance governance framework.

Absolutely. Beyond inspection preparedness, audits and gap analyses strengthen everyday compliance by identifying inefficiencies, standardising practices across functions or markets, and reducing the likelihood of breaches or findings. This proactive approach elevates compliance from a reactive task to a strategic enabler of business integrity.

Simply contact us to discuss your current compliance posture and goals. We’ll work with you to define the scope of the audit, outline an approach tailored to your organisation and jurisdictions, and provide a clear roadmap for readiness improvements and inspection support.

Preparing for a PMCPA audit typically involves reviewing governance structures, SOPs, training programmes, certification and approval workflows, HCP engagement controls, FMV processes, transparency reporting, and monitoring activities against the legal and self-regulatory requirements.

Eunomia Pharma Services supports companies with structured PMCPA audit readiness assessments, gap analysis, and practical remediation planning aligned to Code expectations.

Companies typically respond to audit findings through structured root-cause analysis, development of corrective and preventive action (CAPA) plans, updates to policies and procedures, strengthened governance controls, and targeted training to address gaps and meet legal and self-regulatory obligations.

Eunomia Pharma Services supports organisations in developing practical remediation plans and tracking implementation to strengthen compliance frameworks following audit outcomes.

An effective CAPA plan identifies root causes, assigns responsibilities, sets timelines, and tracks completion through governance oversight.

Eunomia Pharma Services helps design structured CAPA frameworks suitable for PMCPA and internal compliance expectations.

The cost of pharmaceutical compliance audits typically depends on factors such as company size, number of stakeholders involved, geographic footprint, audit scope (e.g. internal review or Prescription Medicines Code of Practice Authority readiness), and whether the organisation is a member of the Association of the British Pharmaceutical Industry or subject to similar self-regulatory requirements in other markets.

Eunomia Pharma Services provides scalable compliance audit support tailored to organisational structure, risk profile, and regulatory expectations.

Preparing for an audit should not be treated as a one-time exercise. Companies are expected to maintain compliance frameworks that operate effectively on an ongoing basis in line with their legal and self-regulatory responsibilities.

Preparation typically includes reviewing governance structures, SOPs, system configuration and approval workflows, roles and responsibilities of personnel, training effectiveness and stakeholders' understanding of requirements, HCP engagement and FMV controls, transparency reporting processes, and monitoring activities. It also involves confirming that materials are appropriately certified, traceable, and stored in compliant systems with clear audit trails. Eunomia Pharma Services supports organisations through structured readiness assessments and helps ensure compliance processes work smoothly in practice, not just ahead of an audit.

The internal audit process in pharmaceutical companies is typically structured in phases to assess both documentation and how compliance works in practice.

It usually starts with scoping and preparation, followed by a documentary compliance review of policies, SOPs, and records. This is then complemented by an operational field audit, including interviews and system walkthroughs, with findings consolidated into a summary report.

The review generally covers key areas such as promotional materials (e.g. brochures, presentations, digital content), sales and promotional practices (including CRM use and activity reporting), benefits and events (meals, congresses, sponsorships), and supporting systems like CRM platforms, approval tools, archiving systems, and training platforms.

Eunomia Pharma Services supports companies in designing and executing structured, risk-based internal audits aligned with industry expectations.