Medical Writing

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.

... 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.We can also take over responsibility for other documents on request.