Knowlegenet is completely integrated regulatory compliant solution that complies electronic submission of dossiers in ectd, ctd and nees effortlessly for all regions. It automates the entire regulatory publishing process. The staff preparing your paper submissions wont be able to easily move into ectd submissions without training and experience, so youll probably need to hire a publisher. Liquent, extedo and lorenz add critical publishing capabilities to industrys first cloudbased application for managing submissions content. With agencies required to produce ever more submissions in electronic formats, the cost and effort involved in converting paperbased documentation into ectd, and other electronic formats, and publishing them to the authorities can be prohibitive for many smaller life sciences organizations. Best practices for a successful ectd submission certara. Liquent, a parexel company is the leading provider of innovative software and professional services designed to support the regulatory business processes of global life sciences companies. Liquent debuts easytouse and automated desktop ectd. Meet the cunesoft team regulatory compliance software and. Electronic document management systems documentum, livelink, mastercontrol, qumas, sharepoint base and compliance solutions running on sharepoint publishing systems csc ectdxpress, extedo ectdmanager, liquent coredossier and insight publisher, lorenz docubridge. Meet the cunesoft team regulatory compliance software.
The ectd is a major new submission standard and liquents latest ectd solution provides a clear path for any life sciences company to confidently and costeffectively start ectd publishing. The regulatory submission process can feel like the final push in a long clinical development journey. As the exclusive us representatives of this innovative software, we are able to offer you customer service in the form of. Submission management your partner in regulatory operations the production of ectds require a special skill and tool set and a comprehensive understanding of the purpose of a dossier combined with future vision. Of the roughly 27 vendors exhibiting at the dia 20th annual document management conference, eight were showing ectd software solutions. Create and manage documents in a 21 cfr part 11 compliant manner and use the ectd module to create your submissions quickly and reliably, all within the same software. Liquent expects this newest version of insight publisher to not only address core crossreferencing requirements, but also the new cross referencing complexities brought on by ectd lifecycle management such as managing cross.
Cunesoft offers a ready to use, prevalidated and highly secure cloud based regulatory compliance suite. Extedos eaeu test submissions generated with ectdmanager have been tested and validated using the agencies validators. Founded in 1992, image solutions, inc isi is a proven market leader in providing submissions solutions, process services and consulting to life sciences companies as a way to improve. She was director of west coast operations for liquent from 1997 to 2000. Regulatory software support freyr has expertise across a diverse set of regulatory submissions and offer highly costeffective and offshorebased or onsite support maintenance of regulatory software. Jun 21, 2016 create and manage documents in a 21 cfr part 11 compliant manner and use the ectd module to create your submissions quickly and reliably, all within the same software. Mono ectd office is an offtheshelf suite of integrated ectd nees vnees software products for the creation, validation, publishing, viewing and manipulation of regulatory documentation for electronic submissions by pharmaceutical companies to regulatory authorities. Our tool kit of regulatory information management rim software works with our support services to help you cross the finish line. Actuarial systems corporation document generation and management system. By enabling you to easily assemble and publish compliant ectd dossiers for new drug applications and subsequent submission updates including the xml backbones for regional content ectd assistant 2. Mono creates and distributes custom software applications and knowledge management solutions. Liquent insight is invaluable for regulatory planning, product detail management, dossier creation, dossier management, project planning and more.
This version is designed for producing national ectds on a singleuser workstation at low volume and comes with a paypersequence token system. Copy of sas viewer software copy of acrobat professional copy of copythispath utility. Otc, provider of livelink, the leading collaboration and content management software for the global enterprise, said today it is introducing a new solution that gives life sciences companies a single, unified environment for managing the complex process of assembling. Founded in 1992, image solutions, inc isi is a proven market leader in providing submissions solutions, process services and consulting to life sciences companies as a. The mastercontrols electronic regulatory submissions software is an integrated quality management suite which is also configurable and easytouse software solution that helps pharmaceutical companies attain and sustain gmp compliance. The multiregion ectd validator that is used by 1,000s. Liquent technologies and services insight user group meeting. Liquent provides technology and outsourcing solutions focused around regulatory submission preparation and tasks, dossier planning, ectd to ctd publishing and. Liquent, with more than 200 biopharmaceutical and life sciences clients worldwide, is a leading provider of software and professional services that support the regulatory business processes of. It all depends on how effective an ectd software is to create, validate, track, publish, view, and manage the entire documentation lifecycle inclusive of complete clinicalpreclinical research data. In 20 a new variant, docubridge one, was introduced. Liquent is the only vendor providing integrated, webbased solutions that manage documents, submissions and product registration details from the time they are created, to their use in regulatory.
The ectd is a major new submission standard and liquent s latest ectd solution provides a clear path for any life sciences company to confidently and costeffectively start ectd publishing. Liquent announces fda submission of full electronic. Mar 04, 20 liquent insightliquent insight is a purposebuilt, enterprise class, comprehensive integrated platformof modular software solutions to support rim needs of life sciences companies. The ectd software provides submissionrelated document templates, as well as preconfigured document types specific to a companys submission.
Master of social sciences from the university of innsbruck and hong kong university. Liquent provides technology and outsourcing solutions focused around regulatory submission preparation and tasks, dossier planning, ectd to ctd publishing and registration tracking capabilities. Innovative ectd, rims, pv and idmp software solutions and services extedo is the only vendor that provides software solutions and services covering the entire regulatory landscape. Qdossier offers all of that through its qualified team members and standardized procedures. The regulatory hurdles faced by life sciences companies are sometimes viewed as slowing progress. In addition, the functionality to be considered is. Qdossier offers ectd publishing and submission management services through its qualified team and inhouse procedures.
Various tools included in the package ensure your work continues flawlessly. Take solutions pharmaready document management system. Electronic submissions for paper people should you do your. Liquent iug presentation feb 20 linkedin slideshare. Fda and are still used exclusively by the agency to evaluate 100% of the electronic submissions it receives. Liquent unveils innovative product registration and. Jun 14, 2004 liquent is the only vendor providing integrated, webbased solutions that manage documents, submissions and product registration details from the time they are created, to their use in regulatory. Senior management positions at liquent, thomson reuters and ditaexchange. Liquent insightliquent insight is a purposebuilt, enterprise class, comprehensive integrated platformof modular software solutions to support rim.
Since our founding in 1994, over 200 companies of varying sizes and product portfolios have produced over 100,000 regulatory submissions using our. Liquent, extedo and lorenz add critical publishing. Brian horner principal support analyst parexel linkedin. Food and drug administration 10903 new hampshire avenue silver spring, md 20993 1888infofda 18884636332 contact fda. Thomson business and global leader in providing regulatory software solutions.
Assist with implimentation, use of, and troubleshooting of software including insight manager, insight publisher, liquent enterprise services rpsles, insight viewer, ectd reviwer, and. See who you know at liquent, a parexel company, leverage your. Basic free, one multiregion subscription, and enterprise serverside secure validation. Electronic document management systems documentum, livelink, mastercontrol, qumas, sharepoint base and compliance solutions running on sharepoint publishing systems csc ectdxpress, extedo ectdmanager, liquent coredossier and. Harmonised technical guidance for ectd submissions in the.
The current version of the ectd specification to be used for ctd modules 25 is the electronic common technical document specification v3. Since the market introduction of liquent insight in 2004, over 40 companies including 10 of the top 20 pharmaceutical companies have selected the liquent insight. Better manage the cost and effort involved in publishing your regulatory submissions. In addition, the functionality to be considered is the ectd. Liquent announces insight for registrations xpress edition. It is the only solution that transforms up to 155 file. Founded in 1996, the company has an innovative and creative approach to software development, producing cuttingedge solutions while respecting budget and time requirements. Regulatory affairs solutions experts lorenz life sciences group. The reasons for this are compliance requirements that are being provided by health authorities to ensure patient safety and to ensure product quality. Meet the best ectd submission software solution available. Harmonizing and streamlining regulatory submissions bio. With agencies required to produce ever more submissions in electronic formats, the cost and effort involved in converting paperbased documentation into ectd, and other electronic formats, and publishing them to the authorities can be prohibitive for many smaller. And while this might seem simple, this complex technical process is actually rife with risk if you lack expertise in medical writing and regulatory publishing. Liquent, with more than 200 biopharmaceutical and life sciences clients worldwide, is a leading provider of software and professional services that support the regulatory business processes of global life sciences companies.
In other words, an ectd is the submission of pdf documents, stored in the ectd directory structure, accessed through the xml backbone and with the files integrity guaranteed by the md5 checksum. Software provider liquent recently confirmed that the contract research organisation has licensed one of its softwareasaservice solutions. The liquent insight platform is the only proven endto. Extedo competitors, revenue and employees owler company. Liquent announces fda submission of full electronic technical document ectd nda utilizing coredossier publishing solution.
The top 10 competitors in extedos competitive set are lorenz, liquent, arisglobal, samarind rms, oracle, acuta, synowledge, ennov solutions, bit. An experienced publisher will expect to be paid like any experienced professional, which means youre adding tens of thousands of dollars per year to your cost of. Liquentconnect is designed to allow organisations to create ectd and nonelectronic submissions without investing massively in their it. Liquent announces fda submission of full electronic technical documentectdnda utilizing coredossier publishing solution. Our tool kit of regulatory information management rim software works with our. Electronic common technical document ectd viewing software. Mono ectd viewer free ectd lifecycle viewer mono ectd. These solutions are varied to address the different needs of todays life science organizations needs that differ based on size, publishing experience, product pipeline, and electronic. Bachelor of science in mathematics from the pennsylvania state university. In addition, liquent has created a free independent web site. Liquent offers a full suite of solutions that ensure that life science organizations are well prepared to take advantage of the ctd and ectd. Extedo is the only vendor that provides software solutions and services covering the entire regulatory landscape. The ectd format is regarded as the principal electronic submission format in eu for human medicinal products and is the. Extedos revenue is the ranked 7th among its top 10 competitors.
Our vision is to keep it as simple as possible while delivering compliance and fulfilling fda 21cfr11, eu annex 11, ich, and gxp requirements. Electronic regulatory submissions software systems mastercontrols electronic regulatory submissions software systems help automate fda electronic submissions in a 21 cfr part 11 compliant manner in the fda environment, the concept of change control is closely interweaved with regulatory compliance. Dec 03, 2015 ectd publishing requires a higher level of experience and technical knowledge than was required for paper submissions. Overview smarter the electronic common technical document ectd publishing software, smoother will be the ectd submission process. Senior management positions at cdc solutions, liquent and nextdocs. Thomson reuters liquent coredossier submission accelerator for ectd. He discovered that many small to medium sized companies felt lost with the rapid change in publishing standards and were disillusioned with both the service and the prices available for this support. When combined with our consulting services, we help you set yourself up for regulatory success. Aquila solutions was founded by josh boutwell in 2010. Electronic submissions for paper people should you do. Liquent announces fda submission of full electronic technical. Collaboration functionality and msword integration enable cross functional teams to collaborate on submissions documents, while ensuring their reliability and security.