EXTEDO - Key Services and Solutions Provider in eRegulatory Affairs White Papers

eCTDmanager™ Suite: Comprehensive Submission Management Solution EXTEDO's eCTDmanager is an off-the-shelf electronic submission management solution that satisfies your requirements for eCTD and non-eCTD submissions, no matter if electronic or paper. eCTDmanager enables you to build, view, validate and publish compliant submissions based on CTD, eCTD, NeeS, IMPD, CTA, eNTA, VNeeS and other submission structures easily.
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EURS is Yours™: Efficient Reviewing of Electronic Submissions EURS is Yours is a multifunctional software solution that serves as an overall eCTD validation and reviewing software tool. It reports whether a submitted eCTD- or NeeS-based application conforms to the official eCTD format. It is especially designed for the validation, acceptance, import, review and maintenance requirements of the European Medicines Agency, the associated national competent authorities (NCAs), and authorities outside of the EU, e.g. the FDA or the Swissmedic.
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PlantOS™ 3 - Register Plant Protection Products the Easy Way EXTEDO PlantOS 3 is an off-the-shelf solution that manages the assembly and compilation of electronic dossiers. The following digital standards for regulatory affairs in Crop Science are supported and can be exported from one single data collection (based on the OECD CADDY table of content): e-PRISM (USA), e-Index (CAN)and CADDY.xml (EU).
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PLmanager™ - Product Labeling Management Simplified EXTEDO PLmanager™ supports life sciences firms that are engaged in the international drug development, approval and maintenance processes. PLmanager is a standardized and open software solution for the creation, review, translation, maintenance and submission of electronic labeling documents, including Company Core Data Sheets (CCDS), and PIM files. It supports internal, as well as integrated, translation and drug approval processes with the EMA.
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PcVmanager™ - One Solution for All of Your Pharmacovigilance Management Needs PcVmanager is a drug safety management software solution based on the E2B and MedDRA standards that enables you to classify, create, review, submit and maintain Pharmacovigilance data and adverse event reports. PcVmanager helps you manage the life cycle of mandatory SUSAR and ICSR reports to the EMA (European Medicines Agency) and the NCAs via our integrated E2B gateway, as well as all reported Serious Adverse Events (SAE) for an overall safety re-evaluation.
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DRAmanager™: Planning and Tracking of Drug Regulatory Activities DRAmanager ensures the fast and smooth functioning of creating and maintaining product and device information and associated activities in accordance with the pharmaceutical, medical and health-related government and regulatory bodies around the world. DRAmanager is a standardized and open software solution for the management of pharmaceutical product information, medicinal product information, medical device information and associated regulatory tasks.
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