对您 eCTD 申报的信心和合规性
Publish regulatory compliant PDF submissions for various Health Authorities with great efficiency
GlobalSubmit PUBLISH enables you to create health authority compliant eCTD submissions. The software enables you to:
- Identify and correct validation errors in real-time with Live Validation
- Automate the creation of hyperlinks and bookmarks with Link
- Efficiently confirm bookmark and hyperlink destinations with CrossCheck
Certara’s GlobalSubmit eCTD software has processed over 1.5 million regulatory submissions.
- 符合 21 CFR 第 11 部分要求
- 每个版本都为您提供验证
- 由监管专家提供培训
- 与行业领先的电子文件管理系统 (eDMS) 无缝集成
- 支持研究和上市申请递交（IND、NDA、ANDA、sNDA、BLA、MAA、DMF、ASMF、NDS 等）
- 为各种卫生当局编制 eCTD 申报文件，包括：
- 美国食品药品监督管理局
- 欧洲药品管理局 (EMA)
- 加拿大卫生部
- 瑞士药品监督管理局
- 澳大利亚医疗用品管理局 (TGA)
- 日本医药品与医疗器械局 (PMDA)
Save time with the most efficient publishing tool in the world
Efficiency in publishing your eCTD submissions is crucial as your regulatory department races to meet deadlines and deliver treatments to patients. Whether you are an experienced publisher or brand new, promptly publishing eCTD submissions can be challenging.
With GlobalSubmit PUBLISH eCTD software, you’ll greatly reduce the number of steps your regulatory professionals must perform to arrive at a validated, high-quality output, which significantly reduces your timelines.
GlobalSubmit Publish 能够通过实时验证功能 (Live Validation) 实时识别和纠正您的错误、自动处理符合监管要求的 PDF 文档，并加快质量控制 (QC) 检查过程，从而简化您的 eCTD 发布工作流。
Reduce risk of technical rejection with Live Validation
Certara’s GlobalSubmit Live Validation assesses the technical validity of regulatory submissions and eliminates the risk of technical rejection. Live Validation checks for over 200 error conditions of varying severity levels, including 40+ PDF checks. In fact, Live Validation has processed over 1.5 million regulatory submissions.
自动处理符合监管要求的 PDF
GlobalSubmit PUBLISH 消除了不计其数的常规、手动发布任务，同时通过自动处理确保 PDF 文档 100% 符合监管要求。当根据符合监管要求的设置自动处理 PDF 文档的选项打开时，该系统就只会生成符合要求的 PDF。以前发布前由用户手动执行的任务现在都由系统执行了，从而实现了省时的目的。符合监管要求的 PDF 属性包括：
- Set navigation to bookmarks panel and page
- 嵌入所有字体
- 继承对书签和超链接的缩放
- 平展注释（不包括超链接）
将 eCTD 申报文件的 QC 检查过程从几小时减为几分钟
With CrossCheck, reduce your QC process of eCTD submissions from hours to minutes! Independent tests show that CrossCheck is 8X faster and 3X more accurate when compared to traditional, manual methods of hyperlink and bookmark QC. CrossCheck displays a link source and destination side-by-side for quick, easy review in real time. 这一创新加快了在构建 eCTD 申报文件时占用您 40% 的工作时间的活动。
Here to help as you need us
Rest assured that if you have a large submission due with limited resources or just need a hand from time to time while internal resources are out of the office, Certara’s Regulatory Operations team can jump right in. Our submission management services include submission leadership, program management and planning, due diligence and readiness preparation, submission compilation, and eCTD publishing. We support applications to all major health agencies, including the FDA, Europe’s EMA, Health Canada, Japan’s PMDA, and China’s NMPA.
