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Resources

Take a look at our regulatory resources, which explain essential details and offer advice on how and when to approach each project.

Regulatory plan

A resource on how to construct a well-thought-out regulatory plan, as well as how this project can bring a return on investment.

Regulatory Plan Resource

Scientific advice and protocol assistance Priority Medicines (PRIME) and Innovative Licensing and Access Pathway (ILAP)

Scientific advice and protocol assistance are critical to the successful development of new medicine for approval in the EU and UK. To find out more about how to plan your scientific advice or protocol assistance, and what fee reductions are available, fill out the form below We have also included advice on PRIME and ILAP.

Scientific Advice and Protocol Assistance (PRIME and ILAP) Resource

Paediatric investigation plan

A paediatric investigation plan (PIP) is a pre-requisite for the submission of a marketing authorisation application (MAA). This resource gives you advice on how and when to submit the PIP. There is also some advice on incentives for completing the PIP.

Paediatric Investigation Plan Resource

Orphan designation

Orphan designation can be critical for commercial success, as well as fee reductions. This resource explains when to submit the orphan designation and how to plan for the maintenance report submission at the time of the MAA. 

orphan-drug-designation

Marketing applications

Preparation of the dossier for a global filing is a significant undertaking, lasting 12–24 months to prepare the submission and address evaluation questions. This guide explains – at a high level – the different considerations in the planning and submission of the MAA and new drug/biologics licence application.

marketing applications

Roadmap to working with Somerville Development Partners

Download our regulatory roadmap to get a step-by-step guide to working with Somerville Development Partners.

Roadmap to working with Somerville Development Partners