This is what founder Dr Tom Oakley said about starting Somerville Development Partners:
“We wanted to gather together regulatory consultants who are at the top of their field, who would look out for the best interests of our clients and who would naturally be a trusted part of their team. We get a real sense of enjoyment and satisfaction from being involved in bringing a new medicine to patients.”
The team at Somerville Development Partners are known as regulatory scientists first and foremost. They take care to gain a foundational understanding of each client’s programme. They excel in making insightful use of each client’s data – integrating their knowledge of the current therapeutic landscape to give clients a strategy that is specific to their objectives. Continuous in-house regulatory-intelligence-gathering focuses on maintaining a deep knowledge of the prevailing clinical science, new medicine approvals and regulatory guidance.
“Somerville is unique in bringing together a team with true expertise in regulatory sciences, combining it with sharp client focus and dedication to delivering successful outcomes on our projects.” Says co-founder Dr Colin Wheeler.
The expertise Somerville Development Partners maintains is especially important for clients developing new cancer medicines, cutting-edge cell and gene therapies and orphan medicines for rare diseases, as the development landscape often evolves quickly in these areas. Peer review is also very important – they make sure every project undergoes peer review, such that they pool knowledge on projects.
Areas of regulatory affairs expertise
Alongside regulatory and scientific expertise, an important part of what makes Somerville Development Partners different is their flexible approach. They recognise that clients often have changing priorities and timelines, and respond accordingly to work in their best interests. Each client is provided with a dedicated point of contact, who will lead the project from start to finish so that every client is given individual attention.
Somerville Development Partners has a particular affinity for helping small and medium-sized enterprises (SMEs) develop innovative medicines. Through EU SME status, Somerville Development Partners can act on behalf of SMEs who do not have a legal entity in the EU, to benefit from the additional support and fee reductions the EMA offers to SMEs.
Somerville Development Partners is a regulatory affairs partner known for scientific expertise, integrity and client care. Whether a well-established pharmaceutical company or a start-up biotech, Somerville Development Partners can help.
Regulatory strategy | PRIME/ILAP/BTD/FTD | Scientific advice | Paediatric plans | Orphan designation | Marketing applications | Medical writing | Due diligence
Tom Oakley PhD
Tom has worked in the pharmaceutical and biotech industries for more than 20 years, mostly in regulatory affairs. He has a doctorate in cancer research (genomic instability and cell cycle control). Tom has supported numerous regulatory projects (scientific advice, orphan, paediatric etc.) throughout his career – including multiple marketing applications for new medicines in different therapeutic areas.
Colin Wheeler MBChB Dip Pharm Med FFPM
Colin is a UK medical doctor by training and holds a Diploma in Pharmaceutical Medicine and is a Fellow of the Faculty of Pharmaceutical Medicine. He has worked in both clinical and regulatory roles throughout his career – and has held leadership positions in pharmaceutical, biotech and consulting companies. With a clinical and regulatory background, Colin brings insightful and nuanced expertise to regulatory projects.
Media Contact
Company Name: Somerville Development Partners
Contact Person: Tom Oakley Phd
Email: Send Email
Country: United Kingdom
Website: https://somerville-partners.com