Dossier Creation

By involving writers and publishers from early on in the development process, you enable us to work with you to proactively develop and manage the red thread from investigational medicinal product dossiers (IMPD) through to the application for marketing authorisation (MA) and other product-related documents, including registries. We can consult on the alignment of the dossier and SmPC with development safety update reports (DSURs), investigator brochures (IBs), periodic benefit‑risk evaluation reports (PBRERs) and risk management plans (RMPs or REMs), to ensure that the red thread remains in tact.

Red Thread can work with you to create document templates that are submission-specific or reusable company wide. Our writers can author documents from single study components, such as case narratives and study reports, to more complex summaries and overviews. We will work with you to maintain the red thread throughout the authoring process.

Our authors also work closely with your publishing teams in order to deliver submission‑ready documents which meet the required regulatory standards. We can provide a quality control (QC) service and will work to your SOPs. Our dossier creation and submission service can be provided as a whole, or in part. Or use our consultants to guide and support you through the process

Our client required a new drug application (NDA) for an eCTD submission in the US that involved parallel authoring of the pivotal clinical study report (CSR), an integrated safety summary (ISS), the clinical summaries of safety and efficacy and the clinical overviews.

Our authors worked with the client’s publishers to create templates for each document and define the overall submission structure. At an early stage of document development, our authors identified the red thread for each document required to support the proposed summary of product characteristics (SmPC). Re-usable content was mapped to the appropriate section of each document. The authors facilitated parallel document reviews and worked with the other functional teams to ensure consistency of message across the dossier and timely deliverables. Our authors worked closely with the publishers to ensure that each document was approved in a submission‑ready format and compiled in an eCTD structure ready for submission to the FDA.