HCL launches eCompliance for Pharmaceutical Firms; eCompliance Suite Helps Manage and Shorten the Complex Regulatory Document Submission Cycle for New Products

BIOWIRE

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.

The 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, process, ultimately reducing the regulatory approval cycle.

"HCL's eCompliance suite, a first of its kind solution in its class, takes our compliance offering to the next level after the launch of easy 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. HCL 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 HCL.

eCompliance Suite Highlights

-- HCL's eCTD Compliance Manager offers complete regulatory submission lifecycle management as per the specifications laid out by International Conference on Harmonization (ICH)

-- The easy Labeling Solution not only streamlines massive amounts of filing data, but also helps organizations better manage product information. This user-friendly browser based interface empowers non-technical business users to easily create, manage and intelligently reuse the product information for filings in other regulated markets.

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.

About HCL's Life Sciences & Healthcare Practice

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. HCL's investments have strong focus on regulatory compliance prescribed by the FDA's CFR, CEC, ISO, HIPAA and meeting technology paradigms surrounding HL7, DICOM, and others. HCL continues to invest in providing tested solutions in arenas such as Pharmacogenomics, medical devices and diagnostics, contract manufacturing, and hospital information systems. The Life Sciences & Healthcare team comprises 1200 people, including regulatory experts, bio technologists and pharmaceutical industry experts. HCL is already working with 9 of the top 15 leading global pharmaceutical companies including Novartis, Aventis etc.

About HCL Technologies

HCL Technologies is one of India's leading global IT Services companies, providing software-led IT solutions, remote infrastructure management services and BPO. Having made a foray into the global IT landscape in 1999 after its IPO, HCL Technologies focuses on Transformational Outsourcing, working with clients in areas that impact and re-define the core of their business. The company leverages an extensive global offshore infrastructure and its global network of offices in 16 countries to deliver solutions across select verticals including Financial Services, Retail & Consumer, Life Sciences Aerospace, Automotive, Semiconductors, Telecom and MPE (Media Publishing & Entertainment). For the twelve-month period ended 30th June 2006, HCL Technologies, along with its subsidiaries, had revenues of US $976 million (Rs. 4,388 crore) and employed 32,626 professionals. For more information, please visit www.hcltech.com

About HCL Enterprise

HCL Enterprise is a leading global technology and IT enterprise with annual revenues of US $3.5 billion (Rs. 15,000 crores). The HCL Enterprise comprises two companies listed in India - HCL Technologies & HCL Infosystems. The 3-decade-old enterprise, founded in 1976, is India's original IT garage start-up. Its range of offerings span Product Engineering, Technology and Application Services, BPO, Infrastructure Services, IT Hardware, Systems Integration, and distribution of ICT products. The HCL team comprises 36,949 professionals of diverse nationalities, who operate from 16 countries including 300 points of presence in India. HCL has global partnerships with several leading Fortune 1000 firms, including leading IT and Technology firms. For more information please visit www.hcl.in

Forward Looking Statements

Certain statements in this release are forward-looking statements, which involve a number of risks, and uncertainties that could cause actual results to differ materially from those in such forward-looking statements. The risks and uncertainties relating to these statements include, but are not limited to, risks and uncertainties regarding fluctuations in earnings, our ability to manage growth, intense competition in IT services including those factors which may affect our cost advantage, wage increases in India, our ability to attract and retain highly skilled professionals, time and cost overruns on fixed-price, fixed-time frame contracts, client concentration, restrictions on immigration, our ability to manage our international operations, reduced demand for technology in our key focus areas, disruptions in telecommunication networks, our ability to successfully complete and integrate potential acquisitions, liability for damages on our service contracts, the success of the companies/ entities in which we have made strategic investments, withdrawal of governmental fiscal incentives, political instability, legal restrictions on raising capital or acquiring companies outside India, and unauthorized use of our intellectual property and general economic conditions affecting our industry. The company does not undertake to update any forward-looking statement that may be made from time to time by or on behalf of the company.

Other product or service names mentioned herein are the trademarks of their respective owners

Source: www.genengnews.com
20th September 2006

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