eCTD content plan
Shape your submissions
and standardize documents and data
For many years, Qdossier developed and improved its home grown eCTD content plan, including support for other dossier formats such as PIP, non-eCTD electronic submissions and ASEAN-CTD to prepare submissions. The eCTD content plan provides a comprehensive planning and overview of the submission outline and drives standardization of documents and data across products and registrations.
Submission content plan benefits
Auto-generated document titles and file names
Auto-generation of document titles and file names for consistency within and across dossiers, transparent eCTD lifecycles, and optimal reuse of documents.
Life cycle management of submission documents
Highlight documents to be replaced, deleted or added as new. Select from different options for granularity (fine or coarse document granularity) and indicate differences in the naming.
Optional and mandatory metadata
Use of optional and mandatory naming attributes for automatic inclusion in syntax for titles and output file names to drive standardization and technical compliance.
Prefilled document headers, footers and properties
Document header information and prefilled document naming properties with naming suggestions to ensure consistent use of metadata and allow for optimal reuse of contents.
Highlight the reuse of contents
Highlight whether multiple occurrences of single documents are present across modules, sequences and products.
Support for regions and different dossier formats
M1 Regional Information for CA, CH, EU and US (Others in development)
ASEAN Parts 2, 3 and 4
Study Tagging Files, CRFs and Datasets
The combined power of submission document templates and content plan
The granularity and naming of the submission document templates and submission content plan are compliant and follow the same principles. Together they form a powerful and practical tool set. Both, the Qdossier submission document templates and submission content plan can also be used (and aquired) separately.
The submission content plan enables authors to apply the best document granularity and to harmonize authoring-, naming-, cross-referencing- and archiving practices. 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 eCTD attributes applicable to the sequence, individual modules and individual documents. For example, 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 places in a dossier.
Implicitly, the content plan serves as a Quality Control tool before dispatch. 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 (without rework) of documentation across products, countries, submission types and formats. It also ensures reliable hits when querying data-, document- and/or dossier repositories.
PDF publishing can be a very cumbersome task and is often on the critical path when working towards submission deadlines. Authoring eCTD ready documents first time right reduces the burden of document publishing to a minimum. The majority of documents are up to 99% submission ready directly after conversion from MS Word to PDF format, and include all navigational aids like bookmarks, hyperlinks within documents and Table(s) of Contents, Tables and Figures, if needed.
Upon request, Qdossier offers fine tuning and customization of the content plan (e.g. to include company specific documents, pick lists and attributes), regular version updates, training and training materials.