Aquila Solutions Announces Support for FDA eCTD 4.0 Submissions

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Oct 08, 2024, 08:44 ET

WARNER ROBINS, Ga., Oct. 8, 2024 /PRNewswire/ -- Aquila Solutions, a leader in regulatory and pharmaceutical management consulting, is excited to announce the acceptance of Electronic Common Technical Document (eCTD) 4.0 submissions by the U.S. Food and Drug Administration (FDA). As part of its commitment to innovation and regulatory compliance, Aquila Solutions is fully prepared to support clients transitioning to the new eCTD 4.0 format, which represents a major leap forward in global regulatory submissions.

The eCTD 4.0 format introduces enhanced capabilities for managing complex data structures and offers greater flexibility in the regulatory submission process. With eCTD 4.0, sponsors benefit from improved versioning, lifecycle management, and enhanced metadata functionality. Aquila Solutions is at the forefront of these advancements, providing services that enable pharmaceutical and biologic companies to navigate this transition smoothly while maintaining full compliance with FDA guidelines.

What eCTD 4.0 Means for Drug Application Sponsors

eCTD 4.0 brings a new standard for submitting, updating, and reviewing regulatory documents. It includes significant changes such as:

Enhanced Lifecycle Management: Improved mechanisms for managing and tracking document versions, helping sponsors ensure accurate and up-to-date submissions.
Metadata-Driven Submissions: More detailed metadata allows for better organization and more efficient submission review processes.
Global Compatibility: eCTD 4.0 aligns with international regulatory frameworks, enabling sponsors to streamline their submissions across multiple regions.

Aquila Solutions is fully equipped to assist clients in understanding and leveraging these features. With a suite of services ranging from eCTD publishing to consulting, Aquila Solutions ensures that submissions meet the rigorous standards set by the FDA and other global regulatory authorities.

Altair eCTD Viewer: Supporting eCTD 4.0

To further support the adoption of eCTD 4.0, Aquila Solutions offers the Altair eCTD Viewer, an advanced tool that allows drug application sponsors to review their submissions exactly as the FDA reviewers do. With Altair, sponsors can easily navigate through the intricate folder structures, access detailed PDF documents, and track submission sequences. Altair supports unlimited sequences, preserving the integrity of eCTD content while providing valuable insights into the overall impact of each sequence.

As eCTD 4.0 is adopted, Altair's ability to handle complex data structures ensures that sponsors remain compliant with evolving regulatory requirements. The viewer's user-friendly interface, combined with powerful audit trails and comprehensive document tracking, provides sponsors with an unparalleled submission management experience.

Aquila Solutions' Expertise in Regulatory Submissions

Since 2010, Aquila Solutions has specialized in offering comprehensive regulatory services, including eCTD regulatory publishing, SPL authoring, and consulting tailored to meet the needs of small to medium-sized pharmaceutical and biologic companies. As a recognized leader in regulatory compliance, Aquila Solutions helps clients navigate complex regulatory environments, reducing risks and accelerating time-to-market for new drugs and therapies.

Aquila Solutions' expertise extends across global regulatory frameworks, including FDA, Health Canada, and the European Medicines Agency (EMA), ensuring that clients' submissions are accepted and reviewed in all key markets. With the introduction of eCTD 4.0, Aquila Solutions is committed to supporting clients through every step of the regulatory submission process, providing the tools, knowledge, and support needed to succeed.

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

Josh Boutwell
[email protected]
404) 496-4171

SOURCE Aquila Solutions