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.

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.

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.

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.

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.

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.

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.

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.

About 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 https://aquilasolutions.us/.

Contact Information

Name: Josh Boutwell

Email: [email protected]

Phone Number: (404) 496-4171

SOURCE Aquila Solutions