Aquila Solutions Launches Altair
Aquila Solutions Launches Altair
Aquila Solutions' expansion to support Health Canada and EU regulatory submissions in Altair further cements its commitment to global compliance. The integration of these additional regulatory frameworks within Altair provides sponsors with the assurance that their submissions will be accepted and reviewed across major markets.WARNER ROBINS, Ga., Sept. 10, 2024 /PRNewswire/ -- Aquila Solutions, a leader in regulatory and pharmaceutical management consulting, proudly announces the launch of Altair. Altair is a cutting-edge eCTD (Electronic Common Technical Document) viewer, now designed to support global regulatory submissions, including Health Canada and EU submissions.
喬治亞州華納羅賓斯，2024年9月10日 /PRNewswire/ — 監管和藥品管理諮詢領域的領導者Aquila Solutions自豪地宣佈推出Altair。Altair是一款尖端的eCTD（電子通用技術文檔）查看器，現在旨在支持全球監管機構提交，包括加拿大衛生部和歐盟提交的文件。
Altair empowers drug application sponsors with a revolutionary tool that mirrors the FDA's review process, providing an unmatched ability to view and analyze regulatory submissions. Sponsors can now understand each sequence's impact on their application, navigate intricate folder structures, and access detailed views of documents within those folders—all in a user-friendly interface.
Altair爲藥物申請發起人提供了一種革命性的工具，該工具反映了FDA的審查流程，提供了無與倫比的查看和分析監管申報的能力。發起人現在可以在用戶友好的界面中了解每個序列對其應用程序的影響，瀏覽錯綜複雜的文件夾結構，並訪問這些文件夾中文檔的詳細視圖。
The viewer offers three distinct perspectives—Cumulative, Current, and Sequence—allowing sponsors to either load unlimited sequences in one step or add them incrementally, all while preserving the integrity of eCTD content. This versatility ensures that submissions meet the rigorous demands of global regulatory standards, including the latest eCTD 4.0 specifications, which manage complex data structures and formats.
該查看器提供三種不同的視角——累積視角、當前視角和序列視角——允許贊助商在一個步驟中加載無限序列或逐步添加序列，同時保持eCTD內容的完整性。這種多功能性確保提交符合全球監管標準的嚴格要求，包括管理複雜數據結構和格式的最新 eCTD 4.0 規範。
Aquila Solutions' expansion to support Health Canada and EU regulatory submissions in Altair further cements its commitment to global compliance. The integration of these additional regulatory frameworks within Altair provides sponsors with the assurance that their submissions will be accepted and reviewed across major markets.
Aquila Solutions擴展業務以支持加拿大衛生部和歐盟在Altair中提交監管申報，這進一步鞏固了其對全球合規的承諾。將這些額外的監管框架整合到Altair中，爲贊助商提供了保證，他們提交的文件將在主要市場得到接受和審查。
One key feature of Altair is its robust document tracking capabilities, offering a clear audit trail of revisions and updates. The viewer also displays comprehensive eCTD metadata for each document, ensuring thorough documentation and adherence to regulatory requirements. Additionally, users can open and review all content documents of any file type directly within Altair. This feature eliminates the need for external applications and enhances collaboration among stakeholders.
Altair 的一個關鍵特點是其強大的文件跟蹤功能，可提供清晰的修訂和更新審計跟蹤。查看器還顯示每份文檔的全面的 eCTD 元數據，確保記錄完整，符合監管要求。此外，用戶可以直接在 Altair 中打開和查看任何文件類型的所有內容文檔。此功能消除了對外部應用程序的需求，並增強了利益相關者之間的協作。
Without Altair, sponsors may face challenges in understanding the impact of each sequence on their regulatory submissions, potentially leading to compliance issues and delays. By offering a clear, organized view of the entire submission process, Altair mitigates these risks and supports the accuracy and efficiency needed for successful regulatory outcomes.
如果沒有 Altair，發起人在理解每個序列對其監管申報的影響方面可能會面臨挑戰，這可能會導致合規問題和延遲。通過爲整個提交流程提供清晰、有條理的視圖，Altair 可以降低這些風險，並支持取得成功的監管結果所需的準確性和效率。
Altair is available through an annual subscription, which includes unlimited applications and sequences, regular updates to meet evolving regulatory standards, and dedicated email and phone support. A limited free version is also available, allowing potential users to explore its full range of features with one application.
Altair 可通過年度訂閱獲得，其中包括無限量的應用程序和序列、滿足不斷變化的監管標準的定期更新以及專門的電子郵件和電話支持。還提供了限量版的免費版本，允許潛在用戶使用一個應用程序探索其全部功能。
About Aquila Solutions
關於Aquila解決方案
Founded in 2010, Aquila Solutions has established itself as a pioneer in providing innovative regulatory and pharmaceutical management consulting services to small and medium-sized pharmaceutical and biologic companies. With a focus on delivering practical solutions that drive regulatory success, Aquila Solutions is dedicated to supporting its clients across the globe. For more information, visit .
Aquila Solutions成立於2010年，已成爲向中小型製藥和生物公司提供創新監管和藥物管理諮詢服務的先驅者。Aquila Solutions專注於提供推動監管成功的實用解決方案，致力於爲全球客戶提供支持。欲了解更多信息，請訪問。
Contact:
Name: Josh Boutwell
Email: [email protected]
Phone Number: (404) 496-4171
聯繫人：
姓名：喬什·布特威爾
電子郵件：[電子郵件保護]
電話號碼：(404) 496-4171
SOURCE Aquila Solutions
來源 Aquila 解決方案
譯文內容由第三人軟體翻譯。