We provide services tailored to each environment to address various challenges related to eCTD creation!
We provide consulting services based on our expertise and technical support for customers who are struggling to prepare for the eCTD submission environment or who have concerns about their current eCTD submission environment and eCTD creation process. Please feel free to contact us if you have any requests. 【We address the following issues】 ■ Establishment of eCTD submission environment ■ Introduction of templates compatible with eCTD ■ QC tasks that do not pose problems for eCTD submissions ■ Publishing tasks (PDF conversion/application information provision) ■ eCTD creation tasks (XML/folder structure) *For more details, please download the PDF or contact us.
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【Flow of Assessment Consulting】 1. Dry Assessment 2. Setting Assessment Items 3. Assessment 4. Current Situation Analysis / Risk Analysis 5. Assessment Report *For more details, please download the PDF or contact us.
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Our company provides IT solutions for the healthcare and life sciences industries. We offer various tools and solutions to streamline the process from the preparation of regulatory submissions to eCTD compilation for those in the pharmaceutical industry, aiming to contribute to the reduction of costs and time in the creation of high-quality regulatory submissions.