Bringing Innovative Medicines to Patients
We are a specialist European regulatory affairs consultancy providing EU and US regulatory expertise to innovative pharmaceutical, biopharmaceutical and biotechnology companies.
Our regulatory areas of expertise
Oncology & Haematology
Opthalmology
Rare Diseases
Cell & Gene Therapies
Small and Medium-sized Enterprise (SME) status
Are you an emerging biotech?
Are you a small pharmaceutical/ biopharmaceutical company?
We are a registered SME with the European Medicines Agency (EMA), through our office in The Netherlands. This means that we can act on your behalf to receive advanced regulatory support and financial benefits associated with SME status.
years of regulatory expertise
clients supported
agency interactions
orphan applications
marketing applications
Regulatory Affairs Services we provide
We offer end-to-end pre-approval regulatory support from early planning to market authorisation.
Regulatory planning & due diligence
Scientific advice & protocol assistance
Priority medicines initiative and innovative licensing & access pathway
Paediatric investigation plan
Orphan applications
Marketing authorization application
Clinical protocol development
Target product profile development & indication prioritization
EU expertise…hands on working with small midsized biotechs in the regulatory process. One stop shop for all regulatory needs with extensive internal expertise and experience.
- Senior Vice President of Global Regulatory affairs (oncology biotech)
Your regulatory affairs experts
Tom Oakley
Founder and Principal Regulatory Affairs Consultant
Sofia Volnte
Director Regulatory Affairs
Eva Anthopoulou
Associate Director Regulatory Affairs
Subscribe to our Monthly Regulatory Intelligence Scan
Our monthly newsletter gives you the latest European and UK regulatory intelligence. We bring you new and interesting approvals; fast-to-market applications, orphan designations; paediatric applications and therapy area-specific news.
You can unsubscribe at any time from the link in the newsletter footer. Read our Privacy Policy here.
What have we accomplished?
Case study
Challenge
A pharmaceutical company planned to submit an MAA in Europe alongside a new drug application (NDA) in the US, for a tyrosine kinase inhibitor. The company wanted a consulting group with regulatory science expertise in oncology.
Solution
We supported the planning and preparation of the CTD for the MAA and NDA, as part of the global filing team. We also led the pre-submission meetings with the European Medicines Agency and Rapporteurs and the responses to the European Medicines Agency's questions during the assessment.
Result
The European Medicines Agency granted marketing authorization approval.
Why do our clients choose Somerville Development Partners?
Expert regulatory professionals
We understand that quoting regulatory guidance doesn’t help you. So, we promise to give you expert technical, regulatory, and scientific advice that has been built upon decades of experience.
Data-driven insights
We make insightful use of the data you share with us. We then integrate our knowledge of the treatment landscape and your data to give you a strategy that is unique to your product development.
Regulatory knowledge
Our expertise in European Regulatory Affairs means that we can offer you a perspective that is truly evidence-based and driven by the latest regulatory science.
Integrated
We will seamlessly integrate into your team and your development strategy. This means that when we support you, we do so with a comprehensive understanding of your corporate objectives and your medicinal product.
Dedicated
We will always provide you with a dedicated point of contact – someone with more than a decade of experience – to lead your project and be accountable.
Adaptable
As a boutique regulatory affairs consultancy, we can adapt to your changing needs and timelines and provide you with the quality time and attention you deserve.
Resources
Scientific advice and protocol assistance are critical to the successful development of a new medicine for approval in the EU and UK.
Find out more about how to plan your scientific advice or protocol assistance, and what fee reductions are available.
Construct a well thought out and nuanced regulatory plan.
Our guide has been designed to help you create your regulatory plan, as well as how this project can bring return on investment.
A paediatric investigation plan (PIP) is a pre-requisite for the submission of a marketing authorisation application (MAA).
The guide provided here gives some advice on how and when to submit the PIP. There is also some advice on incentives for completing the PIP.
Latest Articles
Subscribe to our Monthly Regulatory Intelligence Scan
Our monthly newsletter gives you the latest European and UK regulatory intelligence. We bring you new and interesting approvals; fast-to-market applications, orphan designations; paediatric applications and therapy area-specific news.
You can unsubscribe at any time from the link in the newsletter footer. Read our Privacy Policy here.