Insight Publisher Is Industry's Only eCTD Solution Built On Integrated Regulatory Information Management Platform
PHILADELPHIA and LONDON, Sept. 5 /Xinhua-PRNewswire/ -- Liquent, a Thomson business and global leader in providing regulatory software solutions, information products and related services for the life sciences industry, today announced that SMB & Galephar has selected InSight Publisher to streamline its regulatory platform. InSight Publisher is designed to accelerate the publishing process for drug submissions to the world's regulatory authorities.
InSight Publisher will enable SMB to create all the components of both electronic and paper submissions from a single assembly structure, enhancing efficiency and helping to bring new drugs to the market faster. InSight Publisher is built on the same platform as InSight Manager which offers sophisticated registration management and submission tracking capabilities and the entire platform is adaptable to many different organizational processes and designs, including centralized and decentralized publishing.
"The constantly changing regulatory framework makes it more difficult than ever to develop and register pharmaceutical products," said Philippe Baudier, SMB's CEO. "We're confident that InSight Publisher will shorten our time from finalized documents to the complete eCTD -- making complex compliance simple and seamless."
InSight Publisher also provides other new features to accelerate drug applications:
-- Step-by-step wizards for eCTDs and study reports help to streamline
the creation of submissions and reports that comply with ICH,
Japanese, Canadian, US and other regional specifications;
-- The most complete eCTD Conformity Checking that automatically performs
50 eCTD validation checks, including 32 ICH compliance requirements;
-- Templating capabilities that let companies pre-define the structure of
their content and the placement of paper publishing elements such as
tabs, slip sheets and cover pages;
-- An eCTD import wizard that helps organizations to continue their
lifecycle management of previously completed eCTD submissions.
"Liquent's InSight Publisher is the leading product in regulatory publishing," said Jim Nichols, Liquent's vice president of Product Strategy and Marketing. "Our one-of-a-kind technology is sure to save SMB critical time throughout their publishing process."
Additional information about InSight Publisher is available at http://www.liquent.com .
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, http://www.liquent.com .
About The Thomson Corporation
The Thomson Corporation ( http://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 http://www.scientific.thomson.com .
