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.
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.
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.
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.
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.
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.
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.
About Aquila Solutions
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 https://aquilasolutions.us/.
Contact:
Name: Josh Boutwell
Email: [email protected]
Phone Number: (404) 496-4171
SOURCE Aquila Solutions
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