Case Studies

Brexit

A global pharmaceutical client required urgent implementation, management and delivery of a “Brexit” project, to prepare its Organisation and mitigate the impact of the withdrawal of the UK from the EU.

The project was business-critical due to its high risk of exposure from a large product portfolio with a predominantly UK-based supply chain. The challenges from its very late stage initiation (5 months until the (first) date of Brexit), a parallel business transformation programme, the number of cross functional stakeholders involved and most significantly, its need to retain its UK supply chain until the ‘actual’ date of exit, mandated the rapid assembly of a robust and highly adaptable project team of experienced regulatory professionals.

The Solution

A rapid project team was assembed (8 FTEs), including urgent onboarding to client project, systems and processes.

Regulink deployed industry leading proprietary onboarding strategies and processes developed specifically for clients with urgent resource requirements. This significantly reduced the onboarding time typical with outsourcing companies.

Overall PM responsibilities were set up to work directly with the client internal team & Steering Committee, with direct reporting to the senior leaders.

This approach covered multi-stakeholder interaction with full E2E management.

The Outcome

Risk mitigation strategies and plans successfully prepared the business for each potential date of exit from the EU. All regulatory submissions were approved, according to the highly detailed internally-developed plan, with no rejections and less than 1% RFI.

The business was left fully prepared for the end of the transition period, which included submission-ready packages for immediate implementation and no remaining unforeseen risks to disrupt the business. It was a complete success, which the client was hugely grateful for.

The Stats

400+

Products

1500+

Licences

700+

Approvals

180+

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