Aquila Solutions Announces Solution for ECTD 4.0 Submissions
Aquila Solutions Announces Solution for ECTD 4.0 Submissions
WARNER ROBINS, Ga., Aug. 7, 2024 /PRNewswire/ -- Aquila Solutions, a regulatory and pharmaceutical management consulting leader, has launched Altair, an advanced eCTD (Electronic Common Technical Document) viewer. The tool gives drug application sponsors the ability to view their regulatory submissions just as FDA reviewers view them. Altair allows sponsors to see how each sequence affects their application, to view all sub-folders, and to access a detailed view of PDF documents within those sub-folders.
Aquila Solutions,一家藥品規制和管理諮詢行業的領導者,推出了高級 eCTD(電子共同技術文件)閱讀器 Altair。該工具能讓藥物申請人以 FDA 審核者的視角查看他們的規制提交。Altair 能夠讓申請人了解每個序列對其申請的影響,查看所有子文件夾,並可以查看這些子文件夾中 PDF 文檔的詳細信息。
Altair empowers sponsors to delve deep into their applications, showing them how each sequence impacts the overall submission. This eagle-eye view of the entire submission helps sponsors navigate through the complexities of regulatory submissions.
Altair 讓藥品申請人深入了解其申請,展示每個序列對整個提交的影響。這種鷹眼視圖幫助申請人應對規制提交的複雜性。
The viewer's user-friendly interface offers multiple views—Cumulative, Current, and Sequence—each built to provide distinct insights into the submission process. Whether sponsors are loading unlimited sequences in one step or adding sequences as needed, Altair preserves the integrity of eCTD content without any modifications.
該閱讀器用戶友好的界面提供了多個視圖——累計、當前和序列——每個視圖都爲提供不同的提交過程洞察力而構建。無論申請人一次性加載無限序列還是根據需要添加序列,Altair 都不會對 eCTD 的內容進行任何修改,確保其內容完整性。
eCTD 4.0 is the latest evolution in regulatory submission requirements, with its vigorous tools that manage complex data structures and formats. Being compatible with global regulatory standards, Altair helps sponsors have their submissions accepted and reviewed everywhere.
eCTD 4.0 是規制提交要求的最新演進,具有管理複雜數據結構和格式的強大工具。Altair 與全球規制標準兼容,可以幫助申請人在任何地方使其提交獲得認可和審查。
Altair's powerful functionality also includes the ability to track the history of any document within the submission, offering sponsors a clear audit trail of revisions and updates. It also displays a comprehensive eCTD metadata for every leaf, ensuring thorough documentation and compliance with regulatory requirements.
Altair 的強大功能還包括跟蹤提交中任何文檔的歷史記錄,爲申請人提供修訂和更新的清晰審核追蹤。它還爲每個葉片顯示全面的 eCTD 元數據,確保有詳細和合規的文檔。
Users can open all content documents—whether PDF, Word, or another format—directly within Altair, eliminating the need for external applications. This integration promotes efficiency and enhances collaboration among stakeholders involved in the regulatory review process.
用戶可以直接在 Altair 中打開所有內容文檔——無論是 PDF、Word 還是其他格式——無需使用外部應用,這種集成促進了規制審查過程的效率和增強了各方利益相關者之間的協作。
Sponsors without Altair may have difficulty understanding the impact of each sequence on their regulatory submissions. They may struggle to navigate the intricate sub-folder structures and access the associated documentation. A lack of clarity could hinder accuracy and compliance as they prepare critical documents for submission to regulatory authorities.
沒有 Altair 的贊助人可能難以理解每個序列對其規制提交的影響。他們可能難以瀏覽複雜的子文件夾結構並訪問相關文檔。缺乏明確性可能會妨礙其準確性和遵守要求,因爲他們準備將關鍵文檔提交給監管當局。
Altair is available with an annual subscription that includes unlimited applications and sequences, regular updates to meet evolving regulatory standards, and access to dedicated email and phone support. For those interested in exploring the capabilities of Altair, a limited free version is available, giving potential users the experience of all features with one application.
Altair 提供年度訂閱,包括無限制提交和序列,定期更新以符合不斷變化的監管標準,以及專用電子郵件和電話支持。對於想要探索 Altair 能力的人,有一個限制的免費版本可用,僅允許使用一個應用程序體驗其所有功能。
About Aquila Solutions
關於 Aquila Solutions
Founded in 2010, Aquila Solutions continues to lead the way in providing innovative regulatory and pharmaceutical management consulting services to small and medium pharmaceutical and biologic companies. With a focus on delivering practical solutions that drive regulatory success, Aquila Solutions remains dedicated to supporting clients with their products and services. You can learn more about Aquila Solutions at .
Aquila Solutions 成立於 2010 年,繼續領先提供創新的規制和藥品管理諮詢服務,面向小型和中型製藥和生物公司。專注於提供推動規制成功的實際解決方案,Aquila Solutions 致力於爲客戶提供其產品和服務支持。您可以在 網站上了解 Aquila Solutions 的更多信息。
Contact Information
聯繫信息
Name: Josh Boutwell
姓名:Josh Boutwell
Email: [email protected]
電子郵件:[email protected]
Phone Number: (404) 496-4171
電話號碼:(404) 496-4171
SOURCE Aquila Solutions
SOURCE Aquila Solutions