Regulatory approval and dossier creation require in-depth knowledge of the medical field involved, as well as detailed insights into the value and quality of the science behind a product. For this reason, Meducom is increasingly asked to provide in-depth medical content to support regulatory affairs departments and the submission of dossiers. This may be in the form of writing and/or updating reports, for internal use or as required by the authorities, submission of documents for new indications, submission of variations, or other documents as required. Often, this is accompanied by medical training and education of the regulatory team involved.
During 2021, Meducom was asked by one of its valued clients to develop and write a dossier for submission to EMA for a new indication for an oncological drug in the treatment of metastatic colorectal cancer. For the development of this document, Meducom worked closely together with international experts on the one hand and the pharmaceutical company on the other, to support discussions on the content, compile all available data and literature, draft the submission document, format the document in a template as required by the authorities, and coordinate the internal (medical, marketing, regulatory) and external review and feedback process to allow submission of the dossier.