S-cubed Ltd is pleased to announce an expansion of its European Regulatory Affairs capabilities from our Copenhagen office.
Jakob Sandersen joins the Regulatory Affairs team, as Director of Regulatory Affairs, based in the Danish office. Jakob is a pharmacist by background and has 20 years of Regulatory Affairs experience, working with pharmaceutical, medical device and veterinary products.
Mark Lipscombe, Managing Director of S-cubed Ltd states, “I am delighted to welcome Jakob to the S-cubed Regulatory Affairs team, his background and experience perfectly complements our existing team, and I look forward to working with him.”
S-cubed is an established European company that was founded in Denmark in 2007, followed by the UK office in 2008. S-cubed provides the full range of Regulatory Affairs services to our clients. Over the last 10 years, we have built strong relationships with clients and worked with a wide number of EU regulatory agencies including the EMA, to obtain scientific advice, and apply for EU Orphan Medicinal Product Designation, PIPs and MAAs for clients’ products.
From March 2019, the UK’s relationship with Europe will change. However, S-cubed remains committed to serving our clients from all around the globe and to maintain the continuity of our work in Europe through our Regulatory team in the UK and now also in Copenhagen. Our present and future clients can be assured that our expertise in regulatory affairs, along with our full range of services in the UK, EU and internationally will be continuing regardless of the changing political landscape in the UK.
S-cubed will continue to hold EU SME status to support our SME-qualifying, non-EU clients. We can continue to act as EU Orphan Medicinal Product Designation Sponsor, and European Legal Representative for clinical trials, in addition to providing our full range of consultancy services.
Nicola Wright and Stephen Thompson, Directors at S-cubed, explain that, “The UK’s exit from the EU will create a number of issues and challenges for many, if not all, of the life sciences companies operating in Europe. We are staying in contact with the Regulatory Agencies to monitor any changes in regulatory requirements, and in discussion with client companies to help them prepare for the changes ahead. We look forward to continuing to help and support our clients during this uncertain time.”
About: S-cubed is a European company based in Denmark and the United Kingdom offering flexible solutions, consultancy, in house support, and full-service CRO capabilities. S-cubed specializes in Regulatory Affairs, Quality Assurance, Biometrics, CDISC Standards (implementation and conversion), Business Intelligence, and Project Management. http://www.s-cubed-global.com/
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