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Fast-tracking the regulation submission process
January 2020
by DDNews Staff  |  Email the author
EDIT CONNECT
  Litera
  Yseop

SHARING OPTIONS:

PARIS—Yseop, an artificial intelligence (AI) software company that considers itself a pioneer in natural language generation (NLG), has announced a strategic partnership with Litera, a supplier of document drafting technology. The partnership brings together two complementary service offerings to empower life-sciences companies with solutions for more efficient and effective management of regulatory compliance processes.
 
As the two collaborators note, bringing a new drug to market takes between 10 and 15 years and costs between $1.5 billion and $2.0 billion, adding, “In a context of heightened regulatory scrutiny and obligations, relying on manual reporting systems and complex, resource-intensive and time-consuming processes, can jeopardize the whole investment.”
 
Litera is committed to accelerating the creation, review, formatting and standardization of documents to offer the fastest path to compliance, with a dedicated offering for regulatory, medical affairs and clinical operations specialists. Its solution portfolio (DocXtools for Life Sciences, Change-Pro Premier and Content Companion) offers, the company says, a best-of-breed combination to streamline and accelerate high-quality submissions.
 
“Patients are waiting. This is the most important driving factor we bear in mind when working with life-science companies,” said Matt Miller, Litera’s director of product management. “We are always looking for technologies that can help them complete submissions faster. Yseop’s expertise in AI-powered intelligent automation blends in well with our document processing technology, and we are proud to be able to work collaboratively on offering the best approach to streamline regulatory submission.”
 
Working closely with some leading global leading pharmas, Yseop has developed a specialized expertise in providing automated reporting solutions for medical writers, built on advanced NLG technology. By automating some of the data-heavy and time-consuming manual reporting sections needed to ensure compliance and safety, Yseop’s NLG solution aims to help pharmaceutical companies save significant time and money and get drugs to market faster, with the company’s CEO, Emmanuel Walckenaer, noting, “NLG offers this unique ability to help scale human expertise, and regulatory submission is one of the areas where the benefits it delivers proves the more valuable. We share with Litera the urge to provide life-sciences company with the best technology available.”
 
Code: E012030

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