4 Key Components of a Successful eCTD Submission

Navigating the intricate world of pharmaceutical regulatory compliance demands a meticulous approach and expert guidance from pharma regulatory consultants. At Aquila Solutions, we specialize in offering top-notch pharmaceutical consulting services, including FDA consulting, to help companies achieve seamless eCTD submissions. Let's delve into the four key components that contribute to a successful eCTD submission process.

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Plan Your eCTD Submission

The foundation of a successful eCTD submission lies in thorough preparation. Our team of experienced regulatory professionals excels in creating XML backbones that adhere to stringent DTD requirements. With meticulous organization and structuring of submission documents, we ensure you address all required data.

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Manage Your Documents

Effective tracking of your content approval is vital in steering your eCTD submission toward success. Our experts never send in-process documents to publishers. By granularizing your content as much as possible, we help optimize your submissions for compliance and enhance approval chances.

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Remediate Thoroughly

Efficient project management is a cornerstone of a streamlined eCTD submission process. Our dedicated staff ensures your documents are the correct page size and the layout is correct. Every document must be bookmarked to allow the reviewer to navigate the documents. Links let you direct your reviewer to the connections you think are important. Plus, links make the reviewer's life easier so more links are almost always better.

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Quality Control

QC! QC! QC! Accurate information is essential for regulatory compliance. Make sure to quality-check EVERYTHING before you submit. This is where you ensure you are submitting exactly what you intended. Reserve at least a week to QC larger submissions and larger submissions can be QC'd in large sections, like modules.

At Aquila Solutions, our team of pharma regulatory consultants is committed to guiding you through these key components, ensuring a seamless submission process and regulatory compliance. Contact us today to experience excellence in eCTD submissions and regulatory consulting services.

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