HCL Technologies Ltd. (HCL), India's leading global IT services company, is all set to offer the pharmaceutical industry in the country with product suite, eCompliance a 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 a 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
"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. HCL equips its customer to proactively address end-to-end regulatory compliance, bringing about significant risk reduction." stated Pradep Nair, Vice President - Global Life Sciences and Healthcare practice at HCL.
HCL'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 HCL's innovative IT Solutions.
The Life Sciences & Healthcare practice at HCL delivers IT centric solutions across the pharmaceutical, medical device and hospital industries. The DNA of the practice lies in extension of this knowledge to provide focused IT services and solutions to the customers. The company's investments have strong focus on regulatory compliance prescribed by the FDA'sCFR, CEC, ISO, HIPAA and meeting technology paradigms surrounding HL7, DICOM, and others.
Further it continues to invest in providing tested solutions in areas such as Pharmacogenomics, medical devices and diagnostics, contract manufacturing, and hospital information systems.