PharmaLex in Ireland

• The client was a large multi-national pharmaceutical company for whom PharmaLex provides UK and Ireland regulatory support services.
• The client required PharmaLex to utilise in-house expertise in regulatory, pharmacovigilance and quality management to prepare and guide all BREXIT activities. The client particularly required PharmaLex to plan and lead activities for the CAP conversion process to UK national licences.

• PharmaLex held meetings with the client’s Medical Affairs, regulatory, compliance and lifecycle management leads, to discuss the BREXIT guidance and activities, to fully understand the client’s concerns.PharmaLex created a BREXIT preparedness report summarising key activities for supply chain, regulatory and pharmacovigilance. PharmaLex were able to provide detailed responses to follow up questions.

• PharmaLex created a fully scoped BREXIT plan; to map out regulatory activities, responsibilities and timings. PharmaLex presented the plan to regulatory managers so they could understand the process and ask any questions.

• Based on PharmaLex’s detailed plan the client now has a map of activities; client resource may be allocated and mitigating activities have been put in place. The client is reassured of the processes that are ongoing, in order to ensure regulatory compliance post-transition, and continuity of supply.

PharmaLex took the time to listen to BREXIT concerns and explain the process to a wide internal audience. This allowed for the internal team to focus on their ongoing activities, knowing that BREXIT co-ordination activities actions were being led by PharmaLex.