A Comprehensive Guide to eCTD Baseline Submission

Understanding Baseline Submission

Baseline Submission is a complete and accurate electronic dossier of a Marketing Authorization Application in the Electronic Common Technical Document (eCTD) format. It is used to convert an existing MAA dossier from its current format to eCTD, allowing the applicant to submit it to the regulator electronically.

When and How to Submit an eCTD Baseline

• Baseline submission can be submitted while changing the submission format from NeeS/Paper to eCTD.
• Baseline can also be submitted later in the lifecycle.
• It is also possible to re-baseline a broken eCTD lifecycle submission with prior approval from the appropriate Health Authority.

The Perfect Dossier: Essential Elements for your Baseline Submission Dossier

The content can vary depending on the purpose of the baseline and the region for which it is submitted.

The Strategic Advantages of Baseline Submission

• Health Authority receives all the up-to-date and latest available data.
• The applicant will not need to submit dossier fragments for reference purposes in future submissions.
• The lifecycle management is more efficient for tracking revisions and their history for future application updates.
• Ability to start a clear lifecycle and audit trail
• Faster and more efficient regulatory review
• Improved quality of MAA dossiers as the eCTD validation process checks for errors and inconsistencies, which can help identify and correct any problems before the dossier is submitted to the regulator.

Navigating the Challenges of Baseline Submission

• Time consuming
• Insufficiencies and non-compliance become apparent
• Inability to remove outdated, though never replaced, information
• Inability to add more recent, though never submitted, information
• Timing a submission to avoid conflicts with ongoing regulatory submissions.
• Selecting appropriate software tools for submission creation and management.
• Training publishers appropriately and adequately can be time-consuming and expensive.

Simplifying Baseline Submission with PLG’s Expertise

Considering today’s complex regulatory market, selecting the right partner for baseline submission is crucial. With numerous options available, choosing a partner with expertise, competitive edge, and global reach is essential to ensure successful submission. At PLG, we have the qualities that make us the ideal choice for global baseline submission needs.

Expert Support in Regulatory Publishing at PLG

Our team at PLG has extensive experience in regulatory submissions and has worked on numerous baseline submissions. We navigate complex requirements and ensure dispatch to the concerned Health Authority.

Our team’s competitive edge stems from:

• In-depth knowledge of regulatory requirements
• Proven track record of successful submissions
• Continuous training and professional development

We utilize industry-leading publishing tools with advanced document management systems. We also have automated quality control checks to ensure accuracy, efficiency, and compliance.

With regulatory requirements varying across regions, baseline submission demands a partner with global reach. Our publishers are located across three time zones, so we provide unparalleled support and flexibility. Our global presence enables us to communicate and support around the clock and collaborate seamlessly with clients worldwide.

Making the Right Choice for Baseline Submissions

PLG is the ideal partner for baseline submission, offering unparalleled expertise, a competitive team, and global reach. Our commitment to innovate, advance, and deliver ensures successful submissions and a strong foundation for your product’s lifecycle. Our competitive edge and proven track record have helped our clients; partner with us to navigate the complex regulatory landscape and achieve regulatory success.

Author:

Priya Joshi

Team Lead – Regulatory Affairs Publishing

[email protected]

ProductLife Group