Extedo computer software ottobrunn, bavaria 3,598 followers follow us to get the latest updates on ectd, idmp, our solutions, free webinars and events. Extedo and mastercontrol launch integrated solution at dia. Get traffic statistics, seo keyword opportunities, audience insights, and competitive analytics for extedo. The specialist will serve as the central point of contact for customers questions on the use of our software as well as issues that our customers may encounter. Like extedo, arisglobal also competes in the internet software industry. Meet the best ectd submission software solution available. Optimize compliance with innovative regulatory information solutions from extedo. Pharmaready is a fully integrated webbased edms and ectd submissions solution suite. Extedo and veeva integrate to deliver regulatory submissions. The extedosuite combines innovation with compliance, and quality with usability. Extedo and werum it solutions create partnership to launch. Based in germany, extedo is a leading software and service solutions provider in the field of regulatory information management rim. Apr 30, 2019 salt lake city, april 30, 2019 globe newswire extedo, a leading provider of regulatory information management solutions, today announced the integration of ectdmanager, their proprietary. Extedo is seeking a junior application support specialist for its office located near king of prussia, pennsylvania.
Extedo business partners cognizant technology solutions. Extedo is a leading solutions and services provider in the field of regulatory information management rim. 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. Extedo announces new integration of ectdmanager with. The most comprehensive ectd management software solution in the cloud. Extedo expands and restructures us team due to increased. Job opportunity product owner regulatory information.
Extedo competitors, revenue and employees owler company profile. Electronic common technical document ectd mandatory use for some submissions starts may 2017. Committed to innovation, product excellence and customer success, veeva has over 150 customers, ranging from the worlds largest pharmaceutical companies to emerging biotechs. Jul 21, 2017 rob connelly brings a wealth of experience in regulatory operations and electronic publishing to synchrogenix, a certara company, having developed a variety of internal systems and overseen the submission of marketing applications to several countries during his nearly 20 years. Globalsubmit validate ectd submission validation software. Career in regulatory publishing ectd and submissions. Compared to extedo, arisglobal has 1,100 more employees. Globalsubmit publish simplify complex regulatory processes. Extedo ectdmanager is designed to meet exactly these needs and ensure effortless compliance with regulatory requirements. Visit the industry s most read blog offering expert commentary on regulatory submissions. Sandra hartbach, head of regulatory affairs and it at the austrian cro drehm pharma talks about 10 years experience with extedo s software solution. Extedo s focus is on optimizing clients eregulatory business processes. We offer configurable offtheshelf products as well as customized and integrated solutions.
Extedo is the only vendor in the market that is able to cover the complete regulatory landscape. Regulatory compliance software and services cunesoft. Extedo was founded in 1996 as a department of iabg with a simple vision. Please go through this video and learn about ectd and regulatory submissions filed of reg affairs. Buying ectd software vs outsourcing ectd submissions 08th feb 2016 i sumit gupta as of 4th october 20 u. Innovation to simplify complex regulatory processes. Jun 29, 2015 in response to increasing regulatory requirements such as iso idmp and ectd 4.
Creation and presentation of strategic decision templates for the management on the basis of all market. Extedo uses cookies for technical, performance and marketing reasons. Through partnerships with industryrespected ectd publishing tool vendors, such as lorenz docubridge and extedo ectdmanage, mastercontrol offers integrated ectd publishing solutions that allow users to seamlessly manage the compilation of ectd submissions content and publishing outputs. Ensure effortless compliance using extedo s ectd management software solution. We now offer local support staff, online and onsite training options all conducted in chinese and will shortly deliver our ectd software, ectdmanager, with a localized chinese interface. While isis new suite may be focused on the swiss market, the fact that the software can also be used in line with ectd regulations in many other countries across the world including australia, japan and the us shows how the concept has gone global in recent years. Our software modules can be implemented separately or as a part of a unified regulatory information management solution. Through partnerships with industry respected ectd publishing tool vendors, such as lorenz docubridge and extedo ectdmanage, mastercontrol offers integrated ectd publishing solutions that allow users to seamlessly manage the compilation of ectd submissions content and publishing outputs.
Extedo is a fast growing company and is always looking for motivated and committed people. An analysis of the choice of ectd software and tools, training courses, and regulatory consulting. Arisglobal has been one of extedo s top competitors. Globalsubmit validate is the most robust ectd software platform for assessing the technical validity of electronic regulatory submissions. With ectd submissions becoming mandatory for all submissions within the greek market, is your organization ready. 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. Extedo is the only vendor on the market that is able to cover the complete regulatory. Create, validate, publish, view and manipulate regulatory documentation for electronic submissions by pharmaceutical companies to regulatory authorities.
Extedo and werum it solutions create partnership to launch regulatory information management system solution, called rimanager. We offer end to end regulatory affairs and regulatory operations ectd and nees services to pharmaceuticals, biopharmaceuticals, healthcare, and life sciences for regulated and row market latam, cis, mena, asean, and africa region. In response to increasing regulatory requirements such as iso idmp and ectd 4. Extedo is seeking an application support specialist for its office located near king of prussia, pennsylvania.
About ectd insights this site and related information regarding ectd are provided by extedo. An integration of rlpmanager and ectdmanager covers the complete process. The intention of ectdinsights is to create a platform that gives you an overview about timelines and updates on ectd around the world. May 16, 2017 extedo was founded in 1996 as a department of iabg with a simple vision. Identify and compete against the top sites in your industry. Extedo serves over 700 life sciences customers, both large and small, in 60 countries, including the ema and. Freyr submit is an ectd software tool which helps life sciences companies in creation, validation, publishing, viewing and reporting for electronic regulatory submissions to comply with global health authorities. For ectd submissions within eu, the eu module 1 ectd specification see link below should be used.
Cooperating with industry leading experts, extedo collects ectd knowledge to make your life easier. About extedo extedo is the key software and service solutions provider in the field of regulatory information management rim. With a click on the button you allow extedo to improve the user experience of this website. Globalsubmit software and regulatory services for ectd. For more information about how mastercontrol can help with the solutions necessary to ensure that the ectd software and ectd system a company is using is optimally successful, please feel free to contact a mastercontrol representative. We focus on optimizing our clients eregulatory business processes and are the only vendor that provides solutions covering the entire regulatory landscape. Experience with ectd andor the pharmaceutical industry fda. Providing submissions in ectd get the best ectd submission software on the market here format facilitates a global submission strategy that both reduces the timelines associated with the production and distribution of regulatory submissions, and potentially time to market for sponsors across markets. If you do not see a suitable position, you may also send us an unsolicited application. Extedo is committed to follow the highest standards on data protection. Pharma to market is the australian licensed vendor of the esolutions portfolio of software from lorenz life sciences group. We are happy that you are interested in a job at extedo. Synchrogenixs globalsubmit validate is the industry s most robust software platform for assessing the technical validity of. Guaranteed ich compliance no maintenance needed compile ectd.
To ensure compliance, you need an ectd software solution that enables you to maintain a comprehensive overview of your submission statuses across a number of products within multiple different geographic markets. Veeva systems is a leader in cloudbased software for the global life sciences industry. Extedo is the only vendor on the market that is able to cover the complete regulatory landscape. The chinese ectd standard will be included soon as well. Coming 5th may 2017 ectd submission for new dmfs wil be mandatory in ectd format and all subsequent amendments and annual reports for all the dmfs will be in ectd format only. Visit the industrys most read blog offering expert commentary on regulatory submissions. With ectdmanager, you are able to build, view, validate and publish compliant submissions based on ectd, nees, actd, ecopy, impd, cta, pip, vnees, dmf, asmf and other regional formats. From drug design, to market launch and pharmacovigilance surveillance, extedo s suite of software solutions is involved right from the start. Many large pharmaceutical companies are sitting pretty as the january 1, 2008, deadline approaches for required use of the electronic common technical document ectd for electronic submissions to fda.
Extedo and neotrident invite you to our complimentary webinar about the basics of ectd submissions and chinaspecific details. As the worlds number one supplier of submission management systems with over 1050 installations in over 38 countries and 14 international regulatory agencies, lorenz has built a reputable customer base. Among our available job openings, you can see whether there is a suitable job for you. From drug design, to market launch and pharmacovigilance surveillance, extedo s suite of software solutions is involved right from the start and includes the following components. By using our site, you acknowledge that you have read and understand our privacy notice. Arisglobal is a private company that was founded in 1987 in coral gables, florida. Extedo s regulatory software is the ectd software of choice for more than 600 hundred companies and trusted by over 35 regulatory authorities worldwide. A track record of innovation has vaulted synchrogenixs globalsubmit publish solution to the top tier of the electronic common technical document ectd publishing market. Electronic submissions to gain market approval by authorities can securely be handled by cunesofts ectd module in combination with the regulatory document management module.
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. After this video you will get to learn about ecdt, submissions sections, various software s. More information about the standard can be found at the ich ectd webpage. Its scalable, allinone submission management capabilities meet the requirements for both electronic submissions, such as ectd and nees, and paper submissions. Extedo is the key software and service solutions provider in the field of regulatory information management rim. Ideal for biotechnology companies to manage quality compliance can be provided with cunesofts lean sop management software. Regulatory advice to facilitate your transition to electronic submissions in ectd format. The current version of the ectd specification to be used for ctd modules 25 is the electronic common technical document specification v3. Fda has seen 19771 application in ectd format and with time ectd has been widely accepted by the industry.
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