Simplify your authoring process of eCTD dossiers with eCTDtemplates

Retain consistency, cut down review times and optimize dossier production.

Creating documents for electronic submissions can be a time-consuming, inconsistent process involving many different authors, working with numerous different files.

eCTDtemplates provide a simple way to create consistent and compliant dossiers in eCTD (electronic Common Technical Document) and other formats.

All eCTD dossiers start their life as a set of individual documents, authored around common structures and containing standard information. With each individual author writing in their own style, the resulting documents are often inconsistent in appearance and format. This often leads to a lengthy review, both internally and at the agencies.

Through their library of over 1600 pre-written Microsoft Word templates, eCTDtemplates deliver a common starting point for all your technical documentation. By ensuring consistent authoring standards, it enables authors to focus on content and automate the style. This reduces common errors and provides a harmonized structure for non-regulatory personnel.

Benefits

Speed up the creation of eCTD submissions with automation as part of eCTDmanager.

Designed and developed around industry regulations and best practices.

Regularly updated to ensure compliance with the latest authoring guidance.

Cut down review times with consistent layouts and comprehensive instructional guidelines.

Reduce re-work and speed up approvals

Inconsistent writing styles and non-compliant information within documentation can lead to time-consuming updates and rewrites. At best, this could result in approvals being delayed by the authorities or worse, it can result in agencies refusing to accept files during their technical assessment.

Through the provision of inline guidance text for authors, eCTDtemplates indicate what information needs to be entered into each individual area for each document type. EXTEDO’s eCTDtemplates also ensure that your information is structured consistently and accurately entered. This enables reviewers to quickly locate the information they need and make process reviews and approvals faster.

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Speed up authoring for both Medical Writing and Regulatory Affairs

eCTDtemplates include the EXTEDO Word Toolbar to assist your authors in creating their content. The EXTEDO Word Toolbar contains 60 essential buttons to reduce the time needed to perform the most common authoring tasks in a single click. It can automatically create a Table of Content, Table of Figures or Table of Tables; add footnotes to a table, and remove your hidden text.

Effortless compliance in all your writing

eCTDtemplates provide Effortless Compliance™ with industry best practice and writing guidelines for eCTD documentation. They improve your documentation standards, minimize re-work and optimize time-critical document production processes. This feature helps you remain compliant with every document you produce.

Get your eCTD submission ready, faster with automated hyperlinking and auto-compilation

EXTEDO eCTDtemplates also make it easier for regulatory departments to make documents submission-ready. References can automatically be  created as hyperlinks when the document is converted to PDF. Similarly, the use of heading styles allows for the automatic creation of bookmarks. And last, but not least, eCTDtemplates are prepared for auto-compilation in eCTDmanager. Now, you can import multiple documents into the submission and they will be positioned in the correct sections of the dossier, automatically.

Resources

Services

Business Process and Regulatory Consulting Services

Tailored specifically to the needs of regulatory and related stakeholders, EXTEDO’s business process and regulatory consulting services are designed to support you during and after your eCTD submissions. Through a series of workshops, our team of experienced consultants will establish your business needs, understand your processes, and help you to define the most appropriate implementation approach.

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