The submission content plan enables authors to apply the best document granularity and to harmonize authoring-, naming-, cross-referencing- and archiving practices. In addition, it provides a common understanding across all contributors involved in the preparation and retrieval of regulatory documents and management of a regulatory dossier. 

The content plan guides the publishers regarding the use of eCTD attributes. For instance, applicable to the sequence, individual modules and individual documents. Moreover, it guides the publishers on the lifecycle operation values and the need for creating hyperlinks between documents. In more exceptional cases, it also shows how to manage multiple occurrences of the same document at various locations in a dossier.

Implicitly, the content plan serves as a Quality Control tool before dispatch. For example, it is used for checking the actual naming of documents in the eDMS and eCTD, the completeness of the submission in the electronic submission management tool and the proper lifecycle within submissions. The systematic approach and harmonized definition of document names and the submission outline, results in optimal reusability of documentation across products, countries, submission types and formats. As a result, it ensures reliable hits when querying data-, document- and/or dossier repositories.

Qdossier offers fine tuning and customization of the content plan. For example, by including company specific documents, metadata and terminologies. In addition, we can provide regular version updates, training and training materials.