Building a European compliance framework for expansion

Background

Following the buy-back of key assets, our client expanded its sales operations across multiple European markets, including the UK, France, Italy and Spain. This growth introduced a new level of regulatory complexity, requiring consistent oversight across different jurisdictions and healthcare systems.

The organisation needed to ensure that its expanded sales force operated within the requirements of pharmaceutical regulation, anti-corruption rules and corporate governance standards. At the same time, it was important that compliance measures did not disrupt commercial activity.

To support this transition, the client required a compliance function that could be implemented quickly, operate effectively across multiple countries, and align with both local regulations and global standards.

The LS Law Approach

We approached the engagement by establishing a regional compliance function that combined central coordination with local expertise. Our role was to ensure that compliance was embedded within the business in a way that supported, rather than hindered, commercial operations.

We worked closely with the client’s Global Compliance Officer to design a structure that reflected both the organisation’s risk profile and its operational footprint. To enable rapid implementation, we deployed experienced compliance consultants in key markets, including the UK, France, Italy and Spain.

These consultants provided immediate in-country expertise, ensuring that local regulatory requirements were understood and addressed from the outset. They worked alongside the sales and leadership teams to implement appropriate policies, processes and oversight mechanisms aligned with pharmaceutical industry standards.

We also established ongoing monitoring and support, enabling the organisation to maintain compliance as its operations evolved.

The Outcome

The client established a consistent and effective compliance presence across its European operations within a short timeframe.

The regional compliance function provided clear oversight of sales activities, reducing regulatory risk while allowing the business to continue its expansion without disruption. Local expertise ensured that jurisdiction-specific requirements were addressed, while maintaining alignment with global standards.

The organisation achieved greater operational clarity, with defined processes and responsibilities supporting both compliance and commercial teams. This enabled the sales force to focus on growth, supported by a framework that managed risk in a structured and proportionate way.

We continue to support the client in maintaining and developing its compliance framework as it expands into new markets.