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. 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/ANDA 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, together with the nutraceutical department, novel food dossiers and dossiers for health claim substantiation can be prepared.
For all steps in the regulatory process, a check for the most recent formats and guidance provided by ICH, EMA, FDA, national authorities or EFSA is performed. Kinesis is committed to the sponsors’ timelines for submission.