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 ectdmanager is designed to meet exactly these needs and ensure effortless compliance with regulatory requirements. Based in germany, extedo is a leading software and service solutions provider in the field of regulatory information management rim. Globalsubmit publish simplify complex regulatory processes. Extedo is the only vendor on the market that is able to cover the complete regulatory. Fda has seen 19771 application in ectd format and with time ectd has been widely accepted by the industry. Extedo serves over 700 life sciences customers, both large and small, in 60 countries, including the ema and. 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.
Create, validate, publish, view and manipulate regulatory documentation for electronic submissions by pharmaceutical companies to regulatory authorities. 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 werum it solutions create partnership to launch. Pharmaready is a fully integrated webbased edms and ectd submissions solution suite. Cooperating with industry leading experts, extedo collects ectd knowledge to make your life easier. We focus on optimizing our clients eregulatory business processes and are the only vendor that provides solutions covering the entire regulatory landscape. Career in regulatory publishing ectd and submissions.
For ectd submissions within eu, the eu module 1 ectd specification see link below should be used. Arisglobal has been one of extedo s top competitors. With ectd submissions becoming mandatory for all submissions within the greek market, is your organization ready. Extedo is seeking a junior application support specialist for its office located near king of prussia, pennsylvania.
Guaranteed ich compliance no maintenance needed compile ectd. Get traffic statistics, seo keyword opportunities, audience insights, and competitive analytics for extedo. Sandra hartbach, head of regulatory affairs and it at the austrian cro drehm pharma talks about 10 years experience with extedo s software solution. From drug design, to market launch and pharmacovigilance surveillance, extedo s suite of software solutions is involved right from the start. About extedo extedo is the key software and service solutions provider in the field of regulatory information management rim. Extedo s enabling technology, the extedosuite, is unique in all that it covers within regulatory affairs including. Visit the industrys most read blog offering expert commentary on regulatory submissions. Application support specialist job in wayne, pa extedo, inc. Extedo is the key software and service solutions provider in the field of regulatory information management rim. An integration of rlpmanager and ectdmanager covers the complete process. 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.
The current version of the ectd specification to be used for ctd modules 25 is the electronic common technical document specification v3. 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 is the only vendor on the market that is able to cover the complete regulatory landscape. A track record of innovation has vaulted synchrogenixs globalsubmit publish solution to the top tier of the electronic common technical document ectd publishing market. About ectd insights this site and related information regarding ectd are provided by extedo. Ideal for biotechnology companies to manage quality compliance can be provided with cunesofts lean sop management software. Rlpmanager report level publishing software extedo. Extedo s regulatory software is the ectd software of choice for more than 600 hundred companies and trusted by over 35 regulatory authorities worldwide. 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 a fast growing company and is always looking for motivated and committed people. Among our available job openings, you can see whether there is a suitable job for you. Extedo business partners cognizant technology solutions. Pharma to market is the australian licensed vendor of the esolutions portfolio of software from lorenz life sciences group. Extedo was founded in 1996 as a department of iabg with a simple vision.
Extedo is committed to follow the highest standards on data protection. In response to increasing regulatory requirements such as iso idmp and ectd 4. We are happy that you are interested in a job at extedo. 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. An analysis of the choice of ectd software and tools, training courses, and regulatory consulting. Regulatory advice to facilitate your transition to electronic submissions in ectd format. Experience with ectd andor the pharmaceutical industry fda. 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. Nov 26, 20 extedo is the key software and service solutions provider in the field of regulatory information management rim. Extedo competitors, revenue and employees owler company profile. 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. Extedo and mastercontrol launch integrated solution at dia. By using our site, you acknowledge that you have read and understand our privacy notice.
Visit the industry s most read blog offering expert commentary on regulatory submissions. Like extedo, arisglobal also competes in the internet software industry. More information about the standard can be found at the ich ectd webpage. If you do not see a suitable position, you may also send us an unsolicited application.
Extedo computer software ottobrunn, bavaria 3,598 followers follow us to get the latest updates on ectd, idmp, our solutions, free webinars and events. After this video you will get to learn about ecdt, submissions sections, various software s. The intention of ectdinsights is to create a platform that gives you an overview about timelines and updates on ectd around the world. 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. 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. 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 a leading solutions and services provider in the field of regulatory information management rim. 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. 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. Creation and presentation of strategic decision templates for the management on the basis of all market. Extedo and neotrident invite you to our complimentary webinar about the basics of ectd submissions and chinaspecific details. We offer configurable offtheshelf products as well as customized and integrated solutions. Identify and compete against the top sites in your industry. Veeva systems is a leader in cloudbased software for the global life sciences industry. Synchrogenixs globalsubmit validate is the industry s most robust software platform for assessing the technical validity of. 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. Compared to extedo, arisglobal has 1,100 more employees. Extedo s focus is on optimizing clients eregulatory business processes. Extedo expands and restructures us team due to increased.
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. Jun 29, 2015 in response to increasing regulatory requirements such as iso idmp and ectd 4. Extedo and veeva integrate to deliver regulatory submissions. Electronic common technical document ectd mandatory use for some submissions starts may 2017. Our software modules can be implemented separately or as a part of a unified regulatory information management solution. Today we serve more than 700 customers in 60 countries ranging from small companies to large multinational organizations. Buying ectd software vs outsourcing ectd submissions 08th feb 2016 i sumit gupta as of 4th october 20 u. Job opportunity product owner regulatory information. Pharmaready is specifically designed for regulated life science organizations where ease of installation, ease of use, compliance and affordability are primary business drivers. Please go through this video and learn about ectd and regulatory submissions filed of reg affairs. Extedo is the only vendor in the market that is able to cover the complete regulatory landscape. 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. Meet the best ectd submission software solution available.
Ensure effortless compliance using extedo s ectd management software solution. Extedo and werum it solutions create partnership to launch regulatory information management system solution, called rimanager. Best practices for a successful ectd submission certara. May 16, 2017 extedo was founded in 1996 as a department of iabg with a simple vision.
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. Optimize compliance with innovative regulatory information solutions from extedo. Committed to innovation, product excellence and customer success, veeva has over 150 customers, ranging from the worlds largest pharmaceutical companies to emerging biotechs. Its scalable, allinone submission management capabilities meet the requirements for both electronic submissions, such as ectd and nees, and paper submissions. Extedo uses cookies for technical, performance and marketing reasons. Arisglobal is a private company that was founded in 1987 in coral gables, florida.
Extedo is seeking an application support specialist for its office located near king of prussia, pennsylvania. Regulatory compliance software and services cunesoft. The extedosuite combines innovation with compliance, and quality with usability. Globalsubmit validate is the most robust ectd software platform for assessing the technical validity of electronic regulatory submissions. Innovation to simplify complex regulatory processes.
Globalsubmit software and regulatory services for ectd. Electronic submissions to gain market approval by authorities can securely be handled by cunesofts ectd module in combination with the regulatory document management module. With a click on the button you allow extedo to improve the user experience of this website. The chinese ectd standard will be included soon as well. 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. Extedo announces new integration of ectdmanager with. Globalsubmit validate ectd submission validation software. 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.