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Simplify your authoring process of eCTD dossiers with eCTDtemplates
Retain consistency, cut down review times and optimize dossier production.
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.
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
eCTDtemplates product information
Consisting of a library of over 1300 pre-written MS Word templates, eCTDtemplates is your key to faster, more consistent document delivery. With EXTEDO Word Toolbar included, it’s the only tool you need for effortless document creation.
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.
Education & Training Services
To ensure you get the most out of your purchased solution, we offer detailed training for each product within the EXTEDOpulse solution portfolio. Training sessions are tailored to your individual needs and cover a broad range of technical and regulatory topics.
Technical Consulting
Purchasing a new EXTEDO application is the first step to streamlining business and regulatory processes within your organization. However, ensuring correct installation, implementation and integration is a crucial step in the process of deploying your new solution.