Tom Oakley

Above all—we are Regulatory Scientists. Somerville Development Partners was founded to help innovative pharmaceutical and biotechnology companies bring new medicines to patients. Each consultant at Somerville Development Partners has over 15 years of experience in Regulatory Affairs. We have built our scientific and technical expertise over decades of working in pharmaceutical and biotechnology companies, as well as regulatory consulting. We have been integral to delivering more than: • 50 regulatory agency interactions. • 30 orphan designation applications filed. • 50 Marketing Authorisation Applications (MAAs) submitted. We have supported at least 100 clients with diverse regulatory challenges. As data-driven regulatory affairs consultants, we excel at digging into the data you already have and using it to put you in the strongest position possible with health authorities and national competent authorities. We also understand the importance of constantly evaluating the regulatory landscape for new regulation and legislation across life sciences sectors. We are a registered Small and Medium-sized Enterprise (SME). This means that for our US clients, who do not have a legal entity based in Europe, partnering with us is invaluable to them benefiting from the additional support and fee reductions the EMA offers. We help clients with: • Regulatory strategies • Gap analysis and Due Diligence • Scientific Advice & Protocol Assistance • PRIME and ILAP • Clinical Protocol Development • Orphan designation, strategy and maintenance • Paediatric development requirements • Marketing applications (BLA, NDA and MAA) in the US, EU and UK We have experience across all therapeutic modalities and therapeutic areas – including particular expertise in: • Innovative medicines • Oncology & hemato-oncology • Orphan diseases • Advanced Therapy Medicine Products (ATMPs) • Cell and Gene Therapies • Small and Medium-sized Enterprise support