HCL Technologies launches eCompliance product suite for Pharmaceutical Firms

HCL Technologies Ltd has announced the launch of its eCompliance product suite, a first of its kind complete submissions and labeling solution that facilitates global regulatory compliance. The suite features the Company's eCTD Compliance Manager for creating, publishing and managing eCTD submissions as per the specifications laid out by International Conference on Harmonization (ICH), as well as asy Labeling, a global drug labeling solution that addresses the U.S. FDA’s Structured Product Labeling (SPL) standard, the Physician Labeling Rule (PLR) and European Medical Agency EMEA’s Product Information Management (PIM) compliance.

Drug dossier approval process is an iterative and time-consuming process, often resulting in delays due to erroneous or non-compliant data and Content that might creep in given the manual nature of the dossier submission process. The Company's new asy Compliance suite will help Companies remove errors relating to content compliance and manage this complex, time-consuming process, ultimately reducing the regulatory approval cycle.

The Company's eCompliance suite, a first of its kind solution in its class, takes our compliance offering to the next level after the launch of asy Labeling for SPL compliance last year. Due to the global reach of regulations and the risks of non-compliance citations, regulatory compliance requires a holistic approach rather than events-driven ad hoc Solutions. The Company equips its customer to proactively address end-to-end regulatory compliance, bringing about significant risk reduction. "explained Pradep Nair, Vice President - Global Life Sciences and Healthcare practice at the Company.

The Company's life Sciences and Healthcare practice provides composite solutions to customers in the areas of Biomedical Informatics, Clinical Pharmacogenomics, Clinical Trial Management Solutions, Medical Devices and Hospital Management Systems in compliance with FDA, EMEA & ICH regulations, and enables customers and partners to enrich the quality of patient lives through the Company's innovative IT Solutions.

Source : Equity Bulls

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