Founding Regulatory Affairs

10 years ago, Mark Lipscombe (you can read Mark’s Story here) founded S-cubed Ltd after meeting Scott McGregor in Copenhagen. ‘Initially, Scott and I were working together with a focus on project management and SAS programming and I continued running projects when I returned to the UK, working at Milton Park. While I was there, I finally managed to persuade Stephen Thompson (Director of Regulatory Affairs) to come and work with us, in March 2009, and the company grew from there.’

Growth and Quality Assurance

With just Mark and Stephen working out of an office in Oxfordshire, they started to build a team of people that they knew would ensure the business would be successful and grow. Mark explains, ‘We brought Hazel, Emmanuelle, and Fiona on board with the idea of increasing our capacity for project work. At that stage, we were splitting our time across SAS programming, regulatory affairs and project management. We were right in the middle of a global recession and thinking back now, I was not sure how we were going to grow. However, the one thing that seemed to be constant, despite a time of economic downturn was our regulatory work.’

As the company expanded and work started to flow in, it was clear that demand for quality assurance support was also increasing and the company developed a team of expert subcontractor auditors and an internal team with knowledge of both regulatory and QA. ‘It made sense to bring QA expertise to the table and so S‑cubed Ltd is now the Regulatory Affairs and QA arm of the S-cubed brand. We were also able to persuade Nicola Wright join the team as a Regulatory Affairs Director (you can read Nicola’s Story here); I think Stephen and I wore her down and so she joined in 2011!’

Great Staff and The Copenhagen Office

The key to the success of the S-cubed brand is the long-term service of the staff, and this has been integral to the Regulatory Affairs and QA business. Since 2008, the company has grown to twelve regulatory professionals. ‘By having a stable team, we maintain the continuity of our work and ensure that it is of a consistently high quality, as well as building long term relationships with clients. We don’t compromise, and I am extremely proud of our dedicated, hardworking, staff.’ However, with the imminent changes due to Brexit, and the need to maintain a presence in Europe, Mark knew that there needed to be a bridge built between the UK and the EU. ‘We have a good relationship with EMA and act as the EU representative for numerous SMEs. With our organisational presence in Copenhagen, it made sense to move the company forward and S-cubed Pharmaceutical Services ApS was formed just over a year ago. Our diverse client list continues to grow and now we have an increasing number of Nordic customers too.’

The Future

Success at S-cubed is a product of the ability of the directors to be flexible and adapt to the needs of clients and the global economy. ‘Our clients are global, and over the next year, we want to leverage our strong foundations to create continued growth. As far as I am concerned, Brexit is an opportunity. The current instability in the UK has also been compounded by the relocation of the EMA and the CEO of the MHRA stepping down, so we need to maintain our stable presence across the EU and globally. When we founded S-cubed Ltd in 2008, the world was in turmoil, so nothing has changed really, and we seem to be busier than ever. I am sure the next ten years will be as exciting and challenging as the last ten.’

You can find out more about our Regulatory Affairs Services here.