EXTEDO Showcasing New Submission Content Planning Module at 2012 RAPS Conference
Published: Oct 24, 2012
BERWYN, PA--(Marketwire - October 24, 2012) - EXTEDO, a key Regulatory Information Management solutions provider for life sciences firms, today announced it will be showcasing for the first time SCPmanager™, a new submission content planning module, at the 2012 RAPS Conference in Seattle, Washington. The 2012 RAPS Conference is taking place at the Washington State Convention Center and runs from October 26th through October 30th.
SCPmanager will enable firms to plan submission content on the document level. Users will be able to assign documents to any node of the submission sequence. By adding metadata, such as responsible user and milestones to documents, users can manage submission content to a specific planning level. In addition, SCPmanager provides a graphical overview of planned submission content including timelines, status and resources. Also due to the integration of SCPmanager and eCTDmanager, users will be able to view planned submissions within eCTDmanager.
RAPS attendees can view a demo of SCPmanager at booth number 221. EXTEDO regulatory experts will also be demonstrating the following solutions:
- eCTDmanager Suite™, an all-in-one submission publishing and management solution for eCTD and non-eCTD electronic and paper submissions.
- PcVmanager™, a simple and cost effective drug safety management software solution that enables firms to classify, create, review, submit, and maintain pharmacovigilance data and adverse event reports.
- MPDmanager™, an automated web-based master product database solution that enables companies to manage and submit all regulatory data in the format requested by XEVMPD and IDMP.
- DRAmanager™, a powerful and flexible planning and tracking platform that manages pharmaceutical product, medicinal product, and medical device information as well as all associated regulatory tasks.
"Life sciences firms that will use EXTEDO's SCPmanager to manage the production of scientific and regulatory documents can improve efficiency and transparency when compiling and maintaining submissions, predict timelines more accurately, and allocate the right resources at the right time," stated Martin Schmid, Managing Director for EXTEDO.
EXTEDO is the key software and service solutions provider in the field of Regulatory Information Management. The complete EXTEDOsuite is unique in all that it covers within eRegulatory Affairs: Product Registration Planning & Tracking, Submission Management, Pharmacovigilance Management, Labeling Management and Document Management.
EXTEDO provides configurable off-the-shelf products, as well as customized and integrated solutions. EXTEDO also provides EURS is Yours, the validation, review and approval system for the EMA and more than 25 Regulatory Authorities worldwide.
Today EXTEDO serves more than 700 customers in 57 countries ranging from small companies with less than 25 employees to large multi-national organizations. EXTEDO operates in the following markets for human, veterinary and crop protection: Life sciences, including pharmaceutical, biotech and biopharma, generics, homeopathics and medical devices, healthcare and public sector.
For more information visit www.extedo.com.
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