HCL launches eCompliance for Pharmaceutical Firms

newswatch's picture

eCompliance suite helps manage and shorten the complex regulatory document submission cycle for new products

 

To help pharmaceutical companies easily manage the complex regulatory submissions process, HCL Technologies Ltd. (" HCL "), India 's leading global IT services company, today 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 HCL '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 easy 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. HCL 's new easy Compliance suite will help companies remove errors relating to content compliance  and manage this complex, time-consuming process, ultimately reducing the regulatory approval cycle