As regulatory agencies around the world mandate electronic Common Technical Document (eCTD) formats, pharmaceutical companies must adapt to a complex and highly structured submission process. Whether filing an IND, NDA, ANDA, or DMF, a well-executed submission can significantly impact the speed and success of your product’s review. At Aquila Solutions, we specialize in end-to-end eCTD services — helping clients stay compliant, reduce errors, and streamline their eCTD submission process.
Navigating the eCTD Submission Process: A Step-by-Step Guide for Pharmaceutical Companies
Step 1: Organizing the Core Documentation
High-quality submissions start with clean, complete, and correctly formatted documents. We ensure every component is assembled according to regional and ICH guidelines. We check for missing information, apply consistent formatting, and verify that data meets FDA and global expectations.
Tip: Use document templates and SOPs to standardize content from the start.
Step 2: eCTD Compilation and Publishing
Once documentation is ready and meets all the needed requirements, it’s compiled into an eCTD sequence using specialized publishing software. Aquila Solutions' publishing team converts your data into compliant XML with fully functional hyperlinks, bookmarks, and proper structure. Our rigorous internal validation process minimizes the risk of rejection or delay.
Tip: Build in time for internal reviews and mock submissions.
Step 3: Regulatory Submission and Tracking
After publishing, the eCTD must be submitted via secure regulatory gateways like the FDA, ESG, or EMA Gateway. We manage the technical submission process, monitor for acceptance, and ensure all tracking numbers and acknowledgments are properly documented.
Tip: Confirm all gateway setup steps well in advance of deadlines.
Step 4: Lifecycle Management and Maintenance
Regulatory submissions don’t stop with the initial filing. Every update — whether a response, amendment, or annual report — must be submitted as a new sequence. Aquila provides ongoing lifecycle support, ensuring submission history remains accurate and auditable.
Tip: Maintain a master submission log to track all sequences and correspondence.
With over 40 years of regulatory publishing experience, Aquila Solutions is a trusted partner to pharmaceutical companies navigating the eCTD landscape. Our team handles the heavy lifting, from document prep to final submission, so you can focus on getting your product to market. Ready to streamline your next eCTD submission? Contact Aquila Solutions today to get started.