ZYLiQ Expands Regulatory Writing Automation with Launch of Version 4.0 and New Regulatory Modules

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Oct 22, 2025, 09:17 ET

PRINCETON, N.J., Oct. 22, 2025 /PRNewswire/ -- ZYLiQ, a leader in AI/ML-driven solutions for Regulatory Medical Writing, today announced the release of ZYLiQ Version 4.0, further advancing automation and efficiency in clinical study reporting (CSR) and expanding into new regulatory document modules.

As the recognized industry pioneer in GenAI for regulatory writing, ZYLiQ accelerates CSR development by 75%. The strong rate of customer renewals highlights both the innovation and effectiveness of ZYLiQ's platform in addressing regulatory writing challenges.

Version 4.0 introduces a suite of enhancements for CSR automation, including:

Automatic source-type prediction for user-added sections
Optimized synopsis content creation
GenAI-powered tense conversion, lean writing and in-text summary generation
AI-assisted drafting of Safety & Efficacy conclusion sections

In addition, new modules debut in ZYLiQ 4.0 for other regulatory documents using GenAI:

Safety Narratives – Automatically extracts data from listings, SDTM/ADaM datasets, Patient profiles to rapidly generate safety narratives, with customers reporting a 90% reduction in time to completion.
ICF Generation – Ingests protocol and investigator brochure content to guide writers through automated Informed Consent Form (ICF) creation, incorporating sponsor-specific templates.
PLS - Generates Plain Language Summary using CSR as an input automatically in layman language.
PLPS - Generates Protocol Plain Language Summary automatically in layman language.
Redaction & Anonymization - Mask or anonymize any sensitive information in any documents.

To validate its claims, ZYLiQ offers prospective customers a free two-week pilot, enabling side-by-side comparisons of legacy processes versus ZYLiQ's accelerated automation.

"Our focus on regulatory document automation—rather than diluting efforts across many document types—has allowed us to build an exceptionally effective solution," said Farha Feroze, ZYLiQ's Inventor and Director of Product Management. "With Version 4.0, we are excited to expand beyond CSR and deliver the same level of innovation to other regulatory documents. I am proud of my team's effort towards adoption of advanced technologies and better use cases."

About ZYLiQ

Built on three decades of experience at CRO Symbiance, ZYLiQ combines deep domain expertise in Life Sciences with proven AI/ML innovation and In-depth understanding of customer's pain points.

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