eCTD Review Module

The Electronic Common Technical Document (eCTD) application mandate passed down by the U.S. Food and Drug Administration (FDA) caused myriad problems and headaches across the eDiscovery landscape. The eCTD file format can contain years’ worth of cumulative work product, all of which being critical not only to the application process, but also to any subjective challenge to the application and submission to a regulatory body; as well as within litigation.

Suffice it to say that eDiscovery was simply not prepared to handle the excessive complications and dilemmas eCTD poses to attorneys, litigators, corporate counsel, patent specialist, regulatory proceeding experts, and others encountering these files.

HAYSTACKID LLC anticipated some of the severe challenges relevant parties would face when the FDA’s mandate came into effect and developed its proprietary eCTD Review Module. This is a one-of-a-kind, novel solution that helps to make sense of the extreme complexities found within eCTD, and can assist a range of professionals through the application, litigation, and other management challenges they face with respect to this piece of regulatory compliance.

Our proprietary design decodes the complex eCTD data structure and supporting files, all while preserving important folder structure, metadata, and revision history within Relativity for review.

Haystack’s eCTD Compliance Review Module provides context and structure around documents contained in an eCTD submission immediately upon upload into Relativity, during document review, and through production to another party.

When it comes time for production, folders, revision history, documents, and custom metadata related to files and folders can all be easily produced in typical eDiscovery load file formats, ultimately ensuring that critical context regarding the structure and content of an eCTD submission is preserved as evidence that can be acted upon throughout a matter’s lifecycle.

If you would like to learn more about eCTD Review Module and how it can help your practice, contact one of our expert sales consultants to schedule a demo today.

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