Brexit impact on pharma sector

Brexit Impact on Global Regulatory Affairs

Brexit Impact on Global Regulatory Affairs Department Processes and Systems


The project occurred within a British multinational pharmaceutical company, a world leader in the vaccine market.

Belgium hosts its Global Vaccines Headquarters, which manages a portfolio of over 40 different vaccines for children, adolescents, adults and travellers. This company has therefore its main manufacturing sites located in Wavre, producing over 2 million doses of vaccines every single day, from which 99% are exported to more than 160 countries around the globe.
Considering the importance of the UK market for the company, Brexit represented a major business disruption risk. Indeed, its licenses to supply vaccines to the UK market depended on European procedures defined by the European Medicines Agency (EMA). Hence, with Brexit looming around, there was an opportunity for the Medicines and Healthcare products Regulatory Agency (MHRA, the British medicines agency) to define different regulatory requirements that would invalidate its licenses and prevent the company to supply vaccines to the British market. As a result, the Global Regulatory Affairs needed to reengineer their processes and reconfigure their systems, for which Phinest was mandated.

Our Motion:

Phinest’s consultant was responsible for:
• Defining and modelling of “AS-IS” context, i.e documenting existing processes and systems’ configuration
• Gathering requirements from a large group of stakeholders coming from Regulatory, Legal, Supply Chain, Quality and IT departments.
• Providing Regulatory Senior Directors with strategic scenarios, as Brexit negotiations were still ongoing
• Designing and modelling the “TO-BE” processes and systems’ configuration
• Coordinating the implementation of the “TO-BE” solution
• Defining the Change Management approach and Communication strategy for 500+ impacted stakeholders


Phinest’s consultant achieved:
• The implementation of the new process and systems’ configuration without compromising business continuity, allowing regulatory information to flow to the Supply Chain and Quality departments for the supply of vaccines to the UK market
• Coordination of onshore and offshore business and technical teams
• Delivery of communication and training material to Global Regulatory Affairs and external departments to ensure business continuity (500+ employees)

Hugo Varela Gonzalez, 21st June 2021

1200 801 Phinest

    Start Typing
    Privacy Preferences

    When you visit our website, it may store information through your browser from specific services, usually in the form of cookies. Here you can change your Privacy preferences. It is worth noting that blocking some types of cookies may impact your experience on our website and the services we are able to offer.

    Our website uses cookies, mainly from 3rd party services. Define your Privacy Preferences and/or agree to our use of cookies.