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: 381479@email4pr.com
Phone Number: (404) 496-4171
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SOURCE Aquila Solutions