Our software solutions offer many benefits and added value, providing real time information and accurate reports to management. 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. 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. Educe means an endeavor to develop meaningful from abstract. Health canada announced an update to the mandatory use of the electronic common technical document ectd format. When making the choice to produce your own ectds a number of factors must be considered. Mono creates and distributes custom software applications and knowledge management solutions. Regulatory affairs management ecomplianceplus limited. Fda has seen 19771 application in ectd format and with time ectd has been widely accepted by the industry. 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. Create and manage regulatory guidelines compliant and validated ectd.
In addition, the functionality to be considered is the ectd. Create, validate, publish, view and manipulate regulatory documentation for electronic submissions by pharmaceutical companies to regulatory authorities. Extedo is the key software and service solutions provider in the field of regulatory information management. Document management software and e training software it. Visit the industrys most read blog offering expert commentary on regulatory submissions. The word abstract relates to concepts, ideas, and complex requirements of the customers. Aquila solutions was founded by josh boutwell in 2010. Navitas life sciences pharma ready is a fully integrated, regulatory compliant, webbased suite comprised of document management, training records management, structured product labelling, and ectd publishing solutions. Educe solutions it technology services from sadashiv.
Globalsubmit software and regulatory services for ectd. Educe is duly registered under the indian companies act 1956 in pune, india. 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. Navitas life sciences pharmaready is a fully integrated, regulatory compliant, webbased suite comprised of document management, training records management, structured product labelling, and ectd publishing solutions. Educe solutions pvt ltd in sadashiv peth, pune is one of the leading businesses. Educe solutions pvt ltd, sadashiv peth corporate companies in. The extedosuite combines innovation with compliance, and quality with usability. Medxviews software and service offerings ensure that our clients.
Cunesoft offers a ready to use, prevalidated and highly secure cloud based regulatory compliance suite. Meet the best regulatory information management solution. As of june 1, 2019, the remainder of division 8 regulatory activity types human drugs only must be submitted in ectd format. Our vision is to keep it as simple as possible while delivering compliance and fulfilling fda 21cfr11, eu annex 11, ich, and gxp requirements. The most comprehensive ectd management software solution in the cloud.
The ectd summit expert commentary for regulatory submissions. Fda and are still used exclusively by the agency to evaluate 100% of the electronic submissions it receives. The complete extedosuite is unique in all that it covers within eregulatory affairs. Our software services are implemented with quality processes complying with. We are dedicated to advancing careers of those working to develop new therapies and to protect patient safety. Our intuitive software electronically creates, publishes, and views compliant documents, reports, and. Mono ectd office is a suite of integrated nees ectd software products for the validation, creation, viewing, manipulation and archiving of nees ectd.
Regulatory submission content management solution rscm rscm is software which manages lifecycle of regulatory documents for various regions including ectd, actd and indexes for rest of world row countries. 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. Wyeth has been submitting in ectd format since 2003. Educe solutions pharmaceutical services life sciences. Extedos hosted solutions also cut away the cost of capital intensive hardware. Food and drug administration 10903 new hampshire avenue silver spring, md 20993 1888infofda 18884636332 contact fda. At educe, we believe in providing complete business solutions. Our systems are implemented to provide keyinthehand solutions. Educe is one of the leading companies providing software products and service. Our regulatory information managements smart workflow capabilities allow you to create and assign regulatory tasks across your organization for management, departments, headquarters, and affiliates. Educe solutions pvt ltd educe solutions pvt ltd educe.
Educe is one of the leading companies providing software products and service solutions for the pharmaceutical industry. Ltd is one of the leading companies in india providing software products and solutions for the pharmaceutical sector for. As the exclusive us representatives of this innovative software, we are able to offer you customer service in the form of. Wyeths core business is drug development, not software development. Pharmaceutical services life sciences services educe solutions. Omnicia was founded in san franciscos biotech bay in 2001 by life sciences industry veterans looking to simplify the increasingly complex global electronic submission process with innovative software solutions and expert consulting services. With ectdmanager, you are able to build, view, validate and publish compliant submissions based on ectd, nees, actd, ecopy, impd, cta. Jul 07, 2017 ectd software demo cuneectd cunesoft regulatory compliance online. Harmonised technical guidance for ectd submissions in the eu.
Educe is associated with ichm2 group for ectd portability and compatibility. Ctd software healthcare solutions, professional web site development, custom web graphics, standalone and client server software development, web site hosting services, ecommerce solutions. Various tools included in the package ensure your work continues flawlessly. Ltd is one of the leading companies in india providing software products and solutions for the pharmaceutical sector for more than 17 years. Educe solutions it technology services from sadashiv peth. Rosetta regulatory information management and ectd software. Buying ectd software vs outsourcing ectd submissions 08th feb 2016 i sumit gupta as of 4th october 20 u. Founded in 1996, the company has an innovative and creative approach to software development, producing cuttingedge solutions while respecting budget and time requirements. 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. The extedosuite supports the critical relationship between the. Currently gowrie research pvt ltd has purchased the ectd software from educe. 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.
Our ectd submission software has been built to fulfill regulatory needs holistically and end to end. The ectd format is regarded as the principal electronic submission format in eu for human medicinal products and is the. Navitas life sciences provides great customer service when issues arise, and pharmaready is one of the best ectd tools that i have used during my tenure for a much better price sharath koripally, manager regulatory affairs citron pharma. Our team comprises of software professionals with indepth technical skills and management experts with sound pharma domain knowledge. 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. The software helps you with creation, reuse and batch product updates. When we started submitting in ectd format, software options.
Extedo and veeva integrate to deliver regulatory submissions. Contact ectd nees vnees publishing software solution. The dossier management and the spl software is absolutely user friendly and new tools such as file attachment, spt etc. Mar posted by rob labriola in agencies and regulations, ectd. Best practices for a successful ectd submission certara.
You mentioned during the discussion that wyeth is moving from an inhouse ectd software to an off the shelf one. Educe solutions, sadashiv peth, pune, maharashtra it technology services of document management software, e training software, ectd compilation. The current version of the ectd specification to be used for ctd modules 25 is the electronic common technical document specification v3. The life science training institute helps pharma, biotech, and medical device companies build knowledgeable, compliant workforces by providing training from drug discovery through commercialization. Our aim is to ensure companies are as successful as they have the potential to be. Meet the best ectd submission software solution available. Overview smarter the electronic common technical document ectd publishing software, smoother will be the ectd submission process. Educe solutions has gained popularity in the pharma sector for their vast experience and deep domain expertise in providing electronic dossier management solutions.