Brexit Case Studies: Are You Prepared?

The UK’s decision to leave the European Union will have a significant impact on life science companies in Europe. Companies need to start preparing now to ensure that disruption to their business is minimised once Brexit happens. We can help. In these Brexit Case Studies we look at how we helped two companies better prepare for this seismic geo-political event.

Acorn Regulatory is the only regulatory affairs consultancy in Europe with a dedicated Brexit department. Our team of specialists are working with companies across Europe on issues such as regulatory strategy, EU QPPV requirements, EU Authorised Representative services and  more.

Since June 2016 our Brexit specialists have been assisting board members, senior management and regulatory departments at a diverse range of companies. All of these companies have engaged Acorn Regulatory to help them to navigate through the most tumultuous political decision to impact on the business sector in over half a century.

Our Brexit department draws upon the resources of our expert pharmaceutical, pharmacovigilance, clinical trials and medical device consultants.

What Can We Do?

We can meet with your company and assess the potential impact of Brexit upon your regulatory department. We can then present an assessment of the issues that need to be considered to ensure that you minimise interruption to your business.

We can also offer a service where Acorn Regulatory can act as EU QPPV for pharmacovigilance. At present the majority of EU QPPV’s are based in the United Kingdom. We can assist you in facilitating a smooth transfer of EU QPPV services to a new EU member state. Likewise, our medical device specialists can assist you in transferring your EU Authorised Representative to another EU member state.

Case Study One

In January 2017 our Brexit specialists were engaged by the board of a dynamic European pharmaceutical company. They asked us to present to them on the consequences of Brexit and to advise them on the options that were available to them in a post Brexit economy.

Our team prepared a briefing that considered the wider political issues and the specific implications for the European pharmaceutical company. The presentation was used by the board as a conversation starter for a day long meeting on the implications of Brexit for the company.

Acorn Regulatory pharmaceutical and pharmacovigilance specialists presented to the board and a member of our Brexit team facilitated the day long off-site meeting.

Now, the company has a road map to guide them through the coming years as the UK seeks to extract itself from the EU.

Case Study Two

In mid 2016 we began working with a long established pharmaceutical company to assist them in moving their licensing and head office operation out of the United Kingdom and into another EU member state.

The project involved our team of experts working with the legal, HR,  R&D and regulatory departments of the company.

We assisted the company at every stage of the process. In doing so, we were able to identify cost efficiencies. As a result, the company has moved to a new location in an EU member state that is a committed member of the union.

We now provide EU QPPV and virtual pharmacovigilance services to the company, as we do with many other companies. We have mapped out a comprehensive regulatory strategy for the client and we are now advising them on all licensing issues relating to the European market.

The entire project was project managed by a dedicated team at Acorn Regulatory and reassured the shareholders about their trading options.

The Brexit Experts

Now that Article 50 has been triggered there is a greater need than ever to prepare for the UK’s departure from the European Union. We can help you to navigate the Brexit maze. Speak to us today. Call us in Ireland on 00353 52 61 76 706 or complete the form below and we will get straight back to you.

About the Author
Gemma Robinson, PhD
Managing Director
As Managing Director of Acorn Regulatory, Gemma Robinson is actively involved on client projects on a day to day basis and she leads a team of respected pharmaceutical, medical device, pharmacovigilance and clinical trial experts.  Gemma is also an active contributor to developing and promoting standards in the regulatory affairs profession and she has worked with a number of academic and not for profit organisations to encourage individuals to pursue a career in regulatory affairs and the broader STEM subjects. You can read more articles by Gemma by clicking the link below.
Other articles by Gemma Robinson PhD