This service allows you to use Authoring Pro 2, a writing support template used by many pharmaceutical companies and CROs, in a best-practice format.
The service enables electronic formatting and electronic QC in accordance with the eCTD format required by the pharmaceutical industry, and shortens the time to submission readiness.
It provides a complete environment for writing, including Word templates and training, minimizing the implementation period to the start of writing.
Provide a draft writing regulation of best-practice which includes best-practice style definitions and page setups. This document includes a set of writing guides, following which allows you to quickly define your own rules.
Provide a Word template (.dotm) for Japanese that was created based on the style guide. By using this template, you can eliminate the burdensome task of creating Word templates.
Provide a configuration for Authoring Pro based on the best practice template. The best practice configuration is optimized based on our past implementation know-how and provide more convenient functions for users.
Provide Japanese model documents for Modules 1-3 based on the best practice Word template. CTD numbers, titles, and instructions are preconfigured so that users can begin writing application documents immediately.
Provide a hands-on training for Authoring Pro, and also the Authoring Pro eLearning that users can review all the features later.
Provide support for troubleshootings related to the service, and a website where you can download the program and view FAQs.
If you need to customize the template or configuration, for example, to reflect the wording rules of your company, this option performs a configuration process to apply the rules to meet your needs.
If you need to create application documents or reports in other languages, this option provides several versions of language for the service (Word template / best practice configuratiion / model documents).
Provide an evaluation period of 60 days free of charge upon request.
Issue a quotation and conclude a contract based on feedbacks.
Perform configuration for best pratice as required.
Hands-on training is provided.
Provide technical support once the system is operational.
We provide innovative solutions to the pharmaceutical industry, acting as a facilitator in the creation of application documents.
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