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Removing the Challenges Around Electronic Common Technical Documents

Navigating eCTD to Prevent Costly Delays

The eCTD is a harmonized solution to implement the Common Technical Document electronically and is the standard format for submitting applications, amendments, supplements, and reports to FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER).

Since 2018, the submissions for New Drug Applications (NDAs), Abbreviate NDAs (ANDAs), Biologics License Applications (BLAs), Commercial Investigational New Drug Applications (INDs), and most Master Files follow eCTD specifications. While specific exemptions or waivers do exist, this is a process that has enabled the industry to effectively replace paper submissions.

Understanding eCTD requirements and successfully applying them to regulatory submissions is critical, but the requirements aren’t always simple to navigate, and errors (and frustrations) happen when documents do not fit seamlessly into the eCTD structure. If sponsors need to make last-minute adjustments, development timelines can be put at risk and submissions may be returned by the FDA for a technical rejection. Our team at Halloran understands those risks and challenges.

We’ve also observed that some eCTD vendors don’t offer full-suite capabilities for this type of regulatory submission and rely on external outsourcing to provide FDA-ready documents, which puts the burden on the sponsor to manage the entire process or to take in-house. This process can be difficult for startups to manage and oversee.

Don’t let that be you.

The Halloran Experience

Halloran alleviates all of these burdens and can service your entire document needs from access to templates, formatting assistance, PDF publishing and eCTD creation, and submission.

The technology used at Halloran is trusted by global health authorities like FDA and Health Canada. Therefore, we see what the health authorities see. We remove all of the guesswork from the process so there is no confusion as to how the FDA will handle the publishing of the eCTD.

Our U.S.-based team is experienced and holds an average of 15 years of publishing experience, understands the business, and provides quality work with no offshore resourcing. Each client is assigned a publishing lead who stays with the dossier, knows the content, and the history, learns the client’s preferences, and can be pulled in for additional support as needed.

As industry experts, we are a community focused on sharing our life science insights to make a life-changing impact. Our interdisciplinary team of strategists and implementation experts inspire our work to help you critically think through the toughest, most complex organizational and product development challenges.

We also handle stand-alone document development and formatting for clients that need help publishing Investigational Medicinal Product Dossiers (IMPDs), Clinical Study Reports (CSRs), and other complex or non-eCTD documents. And further, we provide authoring services for IBs, nonclinical summaries, and a variety of nonclinical reports.

Join our community by visiting hallorancg.com to discover our regulatory capabilities and contact us to kickstart the conversation.