EXTEDO is the key software and service solutions provider in the field of Regulatory Information Management. The complete EXTEDOsuite covers: Product Registration Planning & Tracking, Submission Management, Pharmacovigilance Management, Labeling Management and Document Management.
Today EXTEDO serves more than 700 customers in 57 countries including EMA and more than 25 Regulatory Authorities worldwide.
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, (eCTD, CTD, NeeS, CADDY, ePRISM, eIndex, eNTA, vNeeS)
• Pharmacovigilance Management (SUSAR, ICSR, PSUR, E2B)
• Labeling Management and
• Document Management
The EXTEDOsuite is comprised of modules that can be implemented separately or as one Regulatory Information Management platform. The platform allows companies to easily plan, enter, import, share and track relevant regulatory data requested by standards like XEVMPD or IDMP. We provide 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 we serve more than 700 customers in 57 countries ranging from small companies with less than 25 employees to large multinational organizations. EXTEDO operates in the following areas of life sciences: pharmaceutical, biotech and biopharma, generics, homeopathics, medical devices, healthcare, and public sector. EXTEDO is recognized as one of the worldwide leaders in each of our areas of operation.
Registration Planning & Tracking
DRAmanager is a planning and tracking solution that enables you to manage regulatory tasks associated with medicinal product and medical device development. DRAmanager accurately and efficiently keeps registered products compliant from a submission, labeling, and drug safety perspective.
MPDmanager is a standardized database that allows the guided entry and automated imports of all regulatory data requested by XEVMPD and IDMP. For the management of additional product attributes, it enables you to comply with corporate standards.
Pharmacovigilance & Drug Safety
PcVmanager is a drug safety management solution that enables you to classify, create, review, submit, and maintain pharmacovigilance data and adverse event reports in accordance with E2B and MedDRA standards.
Submission Creation & Lifecycle Management
eCTDmanager enables you to easily build, view, validate and publish compliant submissions based on CTD, eCTD, NeeS, IMPD, CTA, eNTA, VNeeS and other submission structures.
DOCmanager is an add-on for eCTDmanager that allows the creation and maintenance of many child dossiers based on one parent dossier and reduces update times for variations.
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 contents): e-PRISM (USA), e-Index (CAN), CADDY.xml (EU) Submission Reviewing & Validation EURS is Yours serves as a complete eCTD validation and reviewing software solution. It reports whether a submitted eCTD- or NeeS-based application conforms to the offi cial format.
EURSvalidator supports you in validating medicinal and veterinary eSubmissions. The validator is used by the majority of European National Authorities including EMA to ensure eCTD and NEES compliance. GLOBALvalidator is an add-on for EURSvalidator that provides enhanced functionality and additional validation sets.
CONTACT For more information, please check our website www.extedo.com, email us: email@example.com or call us:
EXTEDO GmbH (European & Global Headquarters) Einsteinstrasse 30, 85521 Ottobrunn, Germany Phone +49 89 189454-0 EXTEDO Inc. (North America Headquarters) 1235 Westlakes Dr., Suite 285, Berwyn, PA 19312, USA Phone +1 (855) 328 3500