EXTEDO - Key Services and Solutions Provider in eRegulatory Affairs Products

PcVmanager Adverse Event Management
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miniDMS A basic document management system is provided (based on the existing eCTDmanager project database and file system archive). This MiniDMS is smoothly integrated into the project database.
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GECCO GECCO is a light-weight desktop eCTD Viewer that provides a uniform and consistent view of eCTDs in the different regions (CA,EU and US).
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PlantOS.xml Suite EXTEDO's off-the-shelf Submission Management System, PlantOS.xml, is a high-quality and functional product for the straightforward assembly and compilation of compliant electronic dossiers.
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PLmanager - Product Labeling Management The creation, management, translation and submission of labeling information for research and development - or eSubmission processes to the FDA, EMEA or other national competent authorities based on the regional labeling standards structured product labeling (SPL), product information management(PIM) or beyond - represent a business critical regulatory task within the drug approval and maintenance process.
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eCTDmanager Suite Electronic and Paper Publishing All in One Application!
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DRAmanager Drug Information and Registration Management
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EURS is Yours EURS is Yours is a multifunctional software solution that serves as an overall eCTD validation and retrieval software.
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