HAYSTACKID Announces Deployment of New eCTD Compliance Review Module

In response to impending compliance requirements, HAYSTACKID has developed a tool to streamline eCTD management.

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​​Haystack Information Discovery (“HAYSTACKID”), an international eDiscovery and digital forensics solutions provider, announced today the release of its new eCTD Compliance Review Module. Currently, this is the industry’s only available solution for handling review, analysis, and production of electronic Common Technical Document (“eCTD”) files within the Relativity environment.

With the U.S. Food and Drug Administration’s May 2017 compliance submission deadline for all New Drug Applications (NDA), Abbreviated New Drug Applications (ANDA), and Biologics Licensing Agreements (BLA) quickly approaching, the FDA has made it clear that any applications submitted after that date that do not adhere to the new eCTD standards will be automatically rejected.

These new regulatory requirements have caused a paradigm shift in the way Pharmaceutical Manufacturing, Drug Marketing, Biotechnology, and R&D companies now handle their application submissions, which, as a result, have also caused a ripple effect in the legal industry.

"eDiscovery just was not prepared for eCTD. These files are highly complex data structures that are simply not compatible with current eDiscovery processing and review products."

Michael Sarlo

Global Director of eDiscovery

“eDiscovery just was not prepared for eCTD,” said HAYSTACKID Global Director of eDiscovery Michael Sarlo. “These files are highly complex data structures that are simply not compatible with current eDiscovery processing and review products.”

eCTD load files contain deep folder structure levels, or “modules,” correlating to specific document types and relating to various required topics when submitting an application to the FDA for review, renewal, or approval. These applications contain years of cumulative work product, all of which can be critical to any review of the contents contained within.

The complicated structure of eCTD files has spurred a greater need among attorneys, litigators, corporate counsel, patent specialists, and regulatory proceeding experts for robust access to internal metadata related to eCTD submissions.

In response to the market’s need for a solution, HAYSTACKID developed a purpose-built application that enables conversion of eCTD files with a seamless connector directly into Relativity for an optimized review experience, all within seconds.

“Structure is critical with eCTD files, and the Relativity folder tree is a perfect compendium of display,” Jefferey Stevens, HAYSTACKID Chief Technology Officer, explained. “With our new module, everything a user needs to understand about an eCTD submission is available in Relativity, where it can also be dynamically searched, culled, tagged, redacted, and acted on for production or review.”

Since adding the eCTD Compliance Review Module to its Relativity extensibility line-up, HAYSTACKID has become the premier eDiscovery provider in eCTD reviews for the top law firms, corporations, and other relevant entities around the world.

About HAYSTACKID

HAYSTACKID is an international eDiscovery and digital forensics solutions provider, with office locations throughout North America and Europe. HAYSTACKID provides corporate customers and their counsel with cost predictability options that allow accurate budgeting and forecasting of their discovery expenses without the additional cost of software, hardware or implementation fees. HAYSTACKID is headquartered in Boston with offices in New York; Washington, D.C.; Chicago; Dallas; Houston; Los Angeles; San Diego; San Francisco; Beaverton, Oregon; Paris, France; Toronto, Canada; and Frankfurt & Berlin, Germany. 

Press Contact 
media@haystackid.com 
877.9.HAYSTACK (877.942.9782)

Source: HAYSTACKID


Categories: Pharmaceuticals and Biotech, Intellectual Property Law, Healthcare and Medical News

Tags: ectd, eDiscovery, FDA, pharma


About HAYSTACKID

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HAYSTACKID is an international eDiscovery and digital forensics solutions provider, with office locations nation-wide & Europe. HAYSTACKID was recently named one of the fastest growing companies and was ranked number 67 on the Inc. 5000.

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