Tailored expert medical communication is becoming more and more important. With our expertise, Meducom increasingly provides in-depth medical content to support regulatory affairs. This may be in the form of writing and/or updating reports, for internal use or as required by the authorities, submission documents for new indications, submission of variations or other documents as required. Often, this is accompanied by medical training and education of the involved regulatory team.
Last year, for example, Meducom was asked by one of its clients to support the creation of an orphan application submission document for EMA for the indication of a rare gastrointestinal cancer type. For the development of this document, Meducom coordinated the compilation of available data and literature, drafted parts of the submission document, formatted the document in a template as required by the authorities, and coordinated the internal (medical, marketing, regulatory) and external review and feedback process.