Precise documentation: medical writing
Our medical writing team creates medical and scientific documents that are perfectly tailored to meet every demand.
Medical writing for clinical trials ...
We prepare development plans, Investigational Medicinal Product Dossiers (IMDP), Investigator’s Brochures, final reports and much more for clinical trials. We remain active on our clients’ behalf for post-authorisation clinical trials and prepare documents such as module 4 of the value dossier/early benefit assessment (AMNOG).
... for marketing authorisation ...
Our medical writers draft expert reports on the pre-clinical (CTD modules 2.4, 2.6, 4) and clinical (CTD modules 2.5, 2.7, 5) sections of marketing authorisation dossiers. We review the study data provided by the client and conduct full literature research if necessary. We also process deficiency letters from the authorities during the marketing authorisation process.
... for the SmPC and PIL
As part of the marketing authorisation documents, the medical writing team drafts the required summary of product characteristics (SmPC) and the patient information leaflet (PIL), commonly known as the package leaflet. In our role as information officer, we can also take over responsibility for these and other documents on request.
Audit of existing documents
On behalf of our clients, we can evaluate how well-suited existing CTD dossiers are for the marketing authorisation process and for special instances, such as well-established use (WEU) authorisation. We also can provide thorough literature research for our clients and process scientific findings to enable their use in dossiers.