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Medical Writing

Medical writing

Good medical writing is fundamental to communicating complex information about your medicine’s development clearly and accurately.  

Throughout your product’s development, you will be required to reach specific regulatory milestones. These milestones include certain regulatory deliverables that you must submit to regulatory authorities. As part of these regulatory submissions, you will be expected to include certain documents in the form of briefing books, presentation slides and large applications.

We provide medical writing expertise for the full range of regulatory and clinical documents at all stages of your pre-clinical development, including:

  • orphan applications,
  • briefing books,
  •  presentation slides,
  • paediatric investigation plans and pediatric study plans,
  • investigator brochures,
  • protocols,
  • clinical study reports,
  • patient narratives, and
  • complete drafting of the common technical document modules (1-5) for registrational filings.

Clinical trial protocol development

Advising on the design of clinical trials for registration is a key part of the regulatory strategy, as is developing a protocol for your pivotal clinical trials. As your pivotal trial will be a focus of discussion during the Marketing Authorisation Application (MAA) evaluation, your clinical trial protocol must be well written.

How we can help

  • advise on the required study design for registration,
  • identify key opinion leaders,
  • arrange input into the clinical strategy via advisory boards and,
  • provide medical writing for the protocol synopsis and full protocol.

Roadmap

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

years of regulatory expertise

clients supported

agency interactions

orphan applications

marketing applications