Liquent Unveils Innovative Product Registration and Submission Lifecycle Management Solutions.Business Editors/Health/Medical Writers/High-Tech Writers FORT WASHINGTON Fort Washington, military post during the American Revolution, situated on the highest point of Manhattan island, New York City, overlooking the Hudson River opposite Fort Lee, N.J. , Pa.--(BUSINESS WIRE)--June 14, 2004 Liquent InSight(TM) Manager To Be Previewed at 40th Annual DIA Meeting in Washington, D.C. Liquent, Inc. used the 40th Annual DIA Meeting, taking place now in Washington, D.C., to preview the next release of its Insight solutions suite for creating and managing documents and data associated with drug marketing authorizations. The announcement reaffirms Liquent's resolve to offer the only integrated suite of applications for document, submission and product registration management. The focus of Liquent InSight(TM) Manager for Assemblies and Insight Manager for Registrations, both of which will be released in autumn 2004, is on unification. They will be the first and only solutions to provide a centralized cen·tral·ize v. cen·tral·ized, cen·tral·iz·ing, cen·tral·iz·es v.tr. 1. To draw into or toward a center; consolidate. 2. , global view of health product details, documents, and submissions to support collaboration, compliance requirements Compliance requirements are a series of directives established by United States Federal government agencies that summarize hundreds of Federal laws and regulations applicable to Federal assistance (also known as Federal aid or Federal funds). and the electronic Common Technical Document The Electronic Common Technical Document (eCTD) is an interface for the pharmaceutical industry to agency transfer of regulatory information. The content is based on the Common Technical Document (CTD) format. (eCTD). InSight Manager will offer life sciences companies a unique approach to managing their product lines especially when deployed with Liquent's CoreDossier and EZsubs submission publishing solutions as well as the InSight Foundation document management application. Users benefit from a single repository that provides a centralized view of their product portfolio, with the ability to drill down to additional information through a flexible browser-based interface. "I'm very excited to have Liquent preview InSight Manager at this year's DIA event," added Jay Nadler, Liquent President and Chief Executive Officer. "These solutions help reduce compliance risks, increase daily efficiency, and provide maximum revenue opportunity by ensuring products are on track for market approval, and properly maintained over the life of the product. Over the past year, we have been working very closely with a large number of clients to develop InSight Manager for Registrations and InSight Manager for Assemblies in order to assure our clients and the market that our integrated approach to solving a critical business problem will offer newfound new·found adj. Recently discovered: a newfound pastime. Adj. 1. newfound - newly discovered; "his newfound aggressiveness"; "Hudson pointed his ship down the coast of the newfound sea" efficiencies. Many of our clients will begin to deploy Insight Manager to thousands of users across R&D, clinical, and regulatory affairs Regulatory Affairs (RA), also called Government Affairs, is a profession within regulated industries, such as pharmaceuticals, medical devices, energy, and banking. Regulatory Affairs professionals usually have responsibility for the following general areas: The Holistic Approach holistic approach A term used in alternative health for a philosophical approach to health care, in which the entire Pt is evaluated and treated. See Alternative medicine, Holistic medicine. From the regulatory affairs department to manufacturing, there are hundreds of product details that must be analyzed, understood, maintained and revisited, sometimes on a daily basis. Life sciences organizations must be able to confidently and consistently answer questions for every product registered or pending registration. With InSight Manager for Registrations, organizations have information at their finger tips Finger Tips is a television programme by The Foundation for CITV, first broadcast in 2000. Presented by Stephen Mulhern and Fearne Cotton (later replaced by Naomi Wilkinson). The show is about creating models out of household items and aimed at a child audience. to answer such important questions as which licenses are due for renewal, where is a raw material used, and what correspondence has occurred. Offering one of the most robust and flexible data models available, Insight Manager for Registrations provides impact analysis on potential changes to manufacturing details at a moment's notice. InSight Manager for Assemblies manages the entire lifecycle of the submission dossier. It provides a single view of the evolving regulatory file giving the entire enterprise a common understanding of dossier status and composition. In the planning process, it is used to identify the documents required for a submission as well as monitor their level of completion. Built upon Liquent's unparalleled experience with producing submissions, InSight Manager for Assemblies automates much of the status tracking and reporting including Microsoft Excel (tool) Microsoft Excel - A spreadsheet program from Microsoft, part of their Microsoft Office suite of productivity tools for Microsoft Windows and Macintosh. Excel is probably the most widely used spreadsheet in the world. Latest version: Excel 97, as of 1997-01-14. and Project integration. This enables the organization to focus on monitoring its progress against the plan. The complexity associated with creating and tracking multiple submissions doesn't go away after market approval. In fact, companies need to have even greater awareness of submissions and documents in a post-approval environment. The CTD CTD 1 Connective tissue disease, see there 2 Cumulative trauma disorder, see there and eCTD were created to enable new efficiencies in biopharmaceutical research and development and regulatory operations; organizations are able to reuse reuse - Using code developed for one application program in another application. Traditionally achieved using program libraries. Object-oriented programming offers reusability of code via its techniques of inheritance and genericity. the same documents and data in different markets. However this potential is realized only if organizations are able to reuse content without spending an inordinate time locating it, determining its status, and determining its relevance to other regions. InSight Manager for Assemblies brings the value of an eCTD lifecycle viewer to every drug product in the organization by ensuring a common understanding of the regulatory relevance of any document in the corporate repository. The Growing InSight Family The InSight Manager products are part of Liquent's solution suite, Liquent InSight, which integrates enterprise compliance processes including the creation, publishing, consumption, and management of documents. InSight offers seamless integration An addition of a new application, routine or device that works smoothly with the existing system. It implies that the new feature or program can be installed and used without problems. Contrast with "transparent," which implies that there is no discernible change after installation. between the electronic regulatory document management system (ERDMS ERDMS Electronic Records and Document Management System (UK) ), publishing, and lifecycle management - all via an easy-to-use, web interface. Other members in the product family include InSight Foundation - launched in November 2003 - which offers a Documentum(R)-based ERDMS designed from the ground up to optimize document management in support of emerging submission formats such as the Common Technical Document (CTD) and electronic Common Technical Document (eCTD). When launched in 2005, Liquent's next-generation publishing solution - InSight Publisher - will provide an innovative and integrated solution for report and submission publishing. While each InSight product is available as a stand-alone solution, when used together as an integrated suite, they present significant workflow efficiencies to the enterprise that would be difficult to achieve otherwise. The InSight platform will also serve as a basis for future expansion. Research is already underway for initiatives such as Structured Product Labeling (SPL (1) (Systems Programming Language) The assembly language for the HP 3000 series. See assembly language for an SPL program example. (2) (Structured Programming Language) See structured programming. 1. ) as well as support for the SAFE (Secure Access for Everyone) initiative - the BioPharmaceutical Industry standard and infrastructure services necessary to support unique electronic identity credentials, enabling legally enforceable and regulatory compliant electronic signatures, for business-to-business and business-to-regulator transactions. "Liquent is the only vendor providing integrated, web-based solutions that manage documents, submissions and product registration details from the time they are created, to their use in regulatory submissions, through to the end of the product lifecycle Product lifecycle or product life cycle is the course of a product's sales and profits over time. The five stages of each product lifecycle are product development, introduction, growth, maturity and decline. . Life sciences organizations will know how their products are evolving with regard to the regulatory aspects and be able to assess the impact of changes and updates to the applications. The InSight Suite will enable life sciences organizations to quickly adapt to emerging regulatory requirements Regulatory requirements are part of the process of drug discovery and drug development. Regulatory requirements describe what is necessary for a new drug to be approved for marketing in any particular country. and streamline business processes" concluded Nadler. About Liquent, Inc. Liquent, Inc. is the global leader in providing regulatory software solutions, information products, and related services for the life sciences industry. Liquent's software and service offerings help ensure clients meet the strict standards of regulatory authorities Noun 1. regulatory authority - a governmental agency that regulates businesses in the public interest regulatory agency administrative body, administrative unit - a unit with administrative responsibilities 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, Liquent's IDRAC IDRAC International Drug Regulatory Affairs Compendium 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 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's world-class products and expert services. Liquent's headquarters are located in Fort Washington, PA, and its European headquarters reside in Chippenham, UK. Liquent has additional offices in Paris, France; Brunnthal, Germany; and Tokyo, Japan. Liquent is a wholly owned subsidiary Wholly Owned Subsidiary A subsidiary whose parent company owns 100% of its common stock. Notes: In other words, the parent company owns the company outright and there are no minority owners. of Information Holdings Inc. (NYSE NYSE See: New York Stock Exchange :IHI IHI Institute for Healthcare Improvement (Boston, MA, USA) IHI Ishikawajima-Harima Heavy Industries (Japan, ship building, aerospace & others) IHI Institute of History IHI I'd Hit It ). About Information Holdings, Inc. Information Holdings Inc. is a leading provider of information products and services to intellectual property and life science markets. IHI's data businesses, which include MicroPatent(R), Master Data Center(TM) and IDRAC, provide a broad array of databases, information products and complementary services for intellectual property and regulatory professionals. IHI's Liquent unit is a leading provider of life science regulatory intelligence and publishing solutions. |
|
||||||||||||||||

Printer friendly
Cite/link
Email
Feedback
Reader Opinion