LIQUENT EXPANDS CONSULTING SERVICES TO AID LIFE SCIENCES INDUSTRY’S MOVE TO ECTD SUBMISSIONS
Philadelphia, PA USA, London UK - June 14, 2007 — Liquent, a Thomson business, today announced that Liquent Direct®, its regulatory outsourcing service that assists companies with the move to electronic common technical document (eCTD) format, has introduced an on-demand regulatory consulting option for Liquent software clients and a comprehensive package of authoring templates designed to streamline and organize the documentation development process for new drug applications.
Liquent Direct develops and delivers regulatory consulting services to provide valuable assistance for small to mid-sized companies looking to make their initial submissions to the world’s regulatory authorities. By providing new services such as authoring templates and on-demand regulatory support, Liquent supports its software and services clients on their quest to move to eCTD.“Because the FDA has withdrawn its 1999 electronic submission guidance, any company wishing to submit to the FDA electronically after Jan 1, 2008 must do so in eCTD format,” said Jim Nichols, Liquent’s VP of product strategy and marketing, Thomson Scientific. “Companies must comply, or there could be delays in bringing new, innovative products to the pharmaceutical market.”
Liquent is the most established one-stop solutions provider that offers regulatory consultancy, software and related professional services to the industry. The company offers its software customers an on-demand regulatory helpdesk service that complements its technical support/helpdesk by allowing its own technical support staff to direct regulatory questions to subject matter experts in an as-needed model.
Liquent Direct recently completed eCTD submission service for Novalar Pharmaceuticals, Inc. for their novel anesthetic reversal product, NV-101. San Diego-based Novalar Pharmaceuticals is a privately-held dental specialty pharmaceutical company dedicated to developing and commercializing novel oral healthcare solutions. Working with a number of clients like Novalar, the Liquent Direct team has completed 12 original eCTDs and over 185 subsequent sequence submissions.
“Liquent worked very effectively with our organization and truly understood our ‘virtual team’ paradigm, which ultimately contributed to the success of the project,” said Laura A. Navalta, Senior Vice President of Clinical & Regulatory, Novalar Pharmaceuticals. “They possess a strong commitment to meeting client timelines, offered excellent client service and produced a high quality product.”
Jim Nichols added: “Because the market, specifically smaller companies without substantial infrastructure, doesn’t have the resources or expertise to produce eCTD submissions on its own, companies want to know that there are options available to assist them in getting their new products submitted to the FDA. Liquent customers benefit by having a team of regulatory experts available to them, coupled with the necessary tools to help them submit in eCTD format.”
About Liquent Regulatory Solutions
Liquent regulatory solutions provide software, information products, and related services for the life sciences industry. These solutions and services help ensure clients meet the strict standards of regulatory authorities across the world helping them achieve quality, accuracy, and data integrity to deliver regulatory reports and submissions reliably and on time. In addition to technology and services, the Liquent IDRAC database service provides the most comprehensive intelligence on the drug and biologics regulatory environment in 38 of the largest markets in the world.
As a result, 48 of the top 50 global life sciences companies rely on Liquent regulatory solutions to stay current with the latest intelligence and to provide the technology and services to compress the regulatory submissions and approval process, improving speed to market, cost control, and productivity, all of which contribute to ensuring patients’ and physicians’ timely access to new drugs. Over the last decade, more than 5,000 regulatory submissions have been produced using Liquent world-class products and expert services. For more information please visit, www.liquent.com.
About The Thomson Corporation
The Thomson Corporation ( www.thomson.com) is a global leader in providing essential electronic workflow solutions to business and professional customers. With operational headquarters in Stamford, Conn., Thomson provides value-added information, software tools and applications to professionals in the fields of law, tax, accounting, financial services, scientific research and healthcare. The Corporation’s common shares are listed on the New York and Toronto stock exchanges (NYSE: TOC; TSX: TOC).
Thomson Scientific is a business of The Thomson Corporation. Its information solutions assist professionals at every stage of research and development—from discovery to analysis to product development and distribution. Thomson Scientific information solutions can be found at scientific.thomson.com.
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