Legacy Dossier Conversion

Dossiers that exist wholly or partially in paper may need to be converted into an e-submission format. Our authors can review legacy content against current standards and recommend changes to a report component, or summaries and overviews.

Our dossier conversion service is required for the transformation of existing dossiers for use in new territories. Dossiers provided through licensing partners or transferred from other areas of an organisation often need to be adapted for submission into another territory or to incorporate new data. We manage these types of dossiers in the same way as conversion of legacy dossiers. While preserving the original report components, we adapt content and format of the dossier where appropriate and necessary.

Our dossier conversion service includes a review of the suitability of the dossier content and format for the new territory and implementation of the recommended changes.

A client required the conversion of  a legacy dossier to meet current standards and for the content to be updated to incorporate new data for submission into new territories.

The list of clinical studies was defined and categorised for assessment of relevance to Module 5. Archived study reports were retrieved and paper components were scanned. Simple navigation was added to the scanned documents to aid review. Each study report was reviewed against current regulatory standards and against the company pharmacovigilance (PV) database. Missing components located in the archived trial master file (TMF) were scanned and added to the report. New content was authored where necessary, including case narratives for significant adverse events. Components were approved in a submission‑ready format appropriate to legacy studies.