Case Study
Performing a comprehensive EU risk assessment review for a Pharmaceutical Leader
With the integrity of its trade compliance operations under scrutiny and the potential for financial, operational, and reputational fallout, the company's legal team initiated a decisive action: a comprehensive audit of all its European facilities' customs and trade compliance activities. This proactive approach aimed not just to map the terrain of compliance risks across the spectrum but also to forge a path to remediation. Entrusted with this pivotal task, DOJÖ embarked on a meticulous journey to assess, analyse, and advise, turning the lens inward on the company's practices to illuminate a way forward.
The Story
For this major pharmaceutical company, a recent customs audit highlighted significant compliance failures, prompting an urgent review of its practices across Europe. With operations spread across various countries, each facing unique compliance challenges, the company understood the necessity of partnering with an expert to perform a comprehensive and impartial review of its customs and trade compliance activities.
The Approach
DOJÖ's methodology was rigorous and comprehensive, beginning with the establishment of a clear level of materiality. This foundational step ensured that the audit would focus on areas of significant impact, guiding the assessment towards the most material risks.
Armed with this criterion, our team delved into an exhaustive review of the company's customs and trade compliance operations, evaluating financial, operational, and reputational risks across three tiers: low, medium, and high. This stratified approach allowed for a nuanced understanding of the company's compliance landscape, identifying not just areas of non-compliance but also zones of potential vulnerability.
Our engagement transcended mere assessment; it was an exercise in strategic foresight. DOJÖ’s team synthesised findings into a comprehensive (actionable) report, which was then presented to the company's top management. This report did not merely catalogue risks; it also outlined actionable remediation actions, complete with a tailored timeline for execution, ensuring that the path from insight to action was clear and navigable.
The Results
The audit illuminated the contours of risk and compliance across the company's European operations, providing the executive team with a detailed risk map and a clear-eyed view of their compliance posture. The project was completed in 2 months. Key outcomes included:
Identification of compliance risks, categorised by financial, operational, and reputational impact, providing a granular view of areas of concern.
A prioritised set of actionable remediation actions, designed to address identified risks effectively and efficiently.
A strategic timeline for the implementation of remediation actions, facilitating a structured approach to compliance improvement.
Enhanced awareness among top management of the compliance challenges and potential risks facing the company, fostering a culture of proactive risk management.
Establishment of a framework for ongoing compliance monitoring and risk assessment, ensuring that the company remains vigilant and responsive to the dynamic regulatory landscape.
This comprehensive risk assessment marked a turning point for the pharmaceutical company, transforming a moment of vulnerability into an opportunity for strategic compliance enhancement. Through DOJÖ's expert guidance, the company not only navigated the complexities of its current compliance challenges but also laid the groundwork for sustained compliance excellence, safeguarding its financial, operational, and reputational integrity for the future.
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