Bringing innovative medicines to patients

We are a specialist EU regulatory affairs consultancy providing European and US regulatory expertise to innovative pharmaceutical, biopharmaceutical and biotechnology companies.

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Oncology & Haematology

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Opthalmology

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Rare Diseases

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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

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Regulatory planning & due diligence

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Scientific advice & protocol assistance

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Priority medicines initiative and innovative licensing & access pathway

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Paediatric investigation plan

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Orphan applications

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Marketing authorization application

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Clinical protocol development

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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

Tom Oakley
Founder and Principal Regulatory Affairs Consultant

Colin Wheeler

Colin Wheeler
Clinical & Regulatory Affairs Consultant

Vicky Abbot

Vicky Abbott
Expert Regulatory Affairs Consultant

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 choose Somerville Development Partners?

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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.
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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.
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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.

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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.
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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.
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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 (PRIME and ILAP) Resource

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.

Regulatory Plan Resource

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.

Paediatric Investigation Plan Resource

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.

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