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eCTD document templates

Writing in Style

create consistent, transparent and reusable documents for global submissions with our eCTD document templates

Qdossier enables companies to write in style using our full set of eCTD document templates (other formats also available, e.g. ASEAN). The document templates optimize lifecycle management, consistency and avoid duplication of work. Often documents are reworked and duplicated over and over when used for a new product or region. Whereas, the contents remains identical but the submission specific values, like naming, cross references and document headers, vary each time. As a result, duplication is time- and resource consuming and can be avoided by applying the correct authoring style and naming of attributes.

eCTD document templates benefits

Embedded font and paragraph styles

Supports automatic creation of TOC, PDF bookmarks and cross references for optimal navigation and significant reduction of PDF publishing to eCTD readiness.

Structured information in tabular formats

The templates apply tabular formats or bullet lists for factual information, where possible. The factual information is often given as placeholders for factual values.

Multiple options for granularity

Support for coarse and fine granularity (single- or multiple documents) is defined for each CTD subsection. This offers flexibility when outlining your submissions.

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.

Regulatory guidance and experience

Hidden regulatory guidance is given to help the authors. Practical experience is included either as hidden text or in separate manuals for CTD modules and subsections (e.g. M2, 32P and 32S).

Preformatted contents and tables

Pre-formatted text and tables are included for standardised CTD sections. This ensures including consistent information and details across documents, sections and dossiers.

The combined power of eCTD document templates and content plan

The granularity and naming of the submission 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 templates and submission content plan can also be used (and acquired) separately.

Where possible, the templates apply tabular formats or bullet lists for factual information. The factual information is often given as placeholders for factual values. These placeholders are in line with ISO IDMP and/or FDA PQ/CMC terminology. The placeholders can be considered for auto-population of regulatory information from a RIM database (example).

Qdossier, deliberately used default Word as much as possible, to prevent dependency of a Qdossier toolbar installation. Since the introduction of Office 2010, a custom toolbar, called ribbon, can easily be created. If users know this feature, it also allows them to create similar ribbons easily in other Office applications and you can involve any additional author, without purchasing more licenses (example).

PDF publishing can be a very cumbersome task and is often on the critical path when working towards submission deadlines. Authoring eCTD ready documents right first time reduces the burden of document publishing to a minimum. As a result, the majority of documents are up to 99% submission ready directly after conversion from MS Word to PDF format. The PDF will include all navigational aids like bookmarks, hyperlinks within documents and Table(s) of Contents, Tables and Figures, as applicable.

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Joyce van Gerven - Kroot

Joyce van Gerven – Kroot
+31 416 707 998
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