Preparation of submission documents / medical writing
Each stage of development and each submission requires writing or adjusting a set of documents specifically focusing on the needs of that moment. Kinesis is accustomed to drafting high quality documents to support a submission. If applicable, documentation will be written electronic Common Technical Document (eCTD)-ready. For this purpose literature searches and literature overviews can also be performed for well-established, abridged, hybrid or generic applications. The regulatory affairs department can draw upon the full range of expertise available within the Chemical, Manufacturing and Control (CMC), non-clinical and clinical departments of Kinesis for drafting the scientific documentation. In addition, Kinesis can compile and submit a full eCTD dossier in collaboration with third parties.