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Submission document authoring
Concise, consistent and conclusive messaging
Faster review and assessments by unambiguous submission document authoring
Qdossier writers have the skill set to provide the information in an unambiguous way; meaning that factual information will often be provided in tabular formats and bullet lists, rather than narratives. On the contrary, scientific evaluations will be in narratives and focus on unexpected results, rather than summarizing the obvious ones. As a result, the submission document authoring will be concise, resulting in faster review and internal approval. It also helps the assessors to quickly navigate through the dossier and find what they need to allow for swift and proper assessment.
When authoring submission documents our writers use the MS-Word features to allow for right-first-time formatting of the document. Together with the Qdossier templates, these facilitate eCTD-ready PDF files upon rendering. Therefore, post-finalization publishing, which is always on the critical path, is limited to a minimum.
‘I did not have time to write you a short letter, so I wrote you a long one’.
Quote Mark Twain
Submission document authoring is not writing a scientific journal or dissertation
Qdossier writers know how important it is to be concise, to present information only where expected and be consistent and conclusive in messaging.
The majority of regulatory document authors have an academic degree and have been educated to writing in the style of articles for scientific journals, dissertations or theses. Above all, these state-of-art documents need to reflect all what is known in context of that time and not necessarily be conclusive of its impact. Therefore, often academic evaluation conclude with statements that more investigation is needed. But, this is different from regulatory document authoring that must be conclusive and address the impact for the product’s quality, its consistent production, and its risk/benefit ratio to the patient. A statement suggesting that more investigation is needed, would result in a non-approvable dossier, which is not the intention of a marketing authorization application.
In addition, a scientific article or dissertation does not have an internationally accepted structure, whereas a regulatory documents must have a home a Common Technical Document (CTD). The CTD is highly structured and consistently structured. Hence, the assessors of the CTD are familiar with the structure of a CTD. Therefore, it does not require cross references to obvious locations.
Qdossier has developed document templates supporting lean authoring, by providing tabular format templates for presenting factual information for easy interpretation.
Support for both emerging and established pharmaceutical companies in defining and executing regulatory strategic activities.
The content plan enables authors to apply the best document granularity and to harmonize authoring-, naming-, cross-referencing- and archiving practices.