5 Reasons to choose the EXTEDOsuite for Regulatory Information ...
5 Reasons to choose the EXTEDOsuite for Regulatory Information ...
5 Reasons to choose the EXTEDOsuite for Regulatory Information ...
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The <strong>EXTEDOsuite</strong> as seen below is<br />
comprised of modules that can be<br />
implemented separately or as one<br />
Regula<strong>to</strong>ry In<strong>for</strong>mation Management<br />
plat<strong>for</strong>m. The plat<strong>for</strong>m allows companies<br />
<strong>to</strong> easily plan, enter, import,<br />
share and track relevant regula<strong>to</strong>ry<br />
data requested by standards like<br />
XEVMPD or IDMP.<br />
5 <strong>Reasons</strong> <strong>to</strong> <strong>choose</strong> <strong>the</strong><br />
<strong>EXTEDOsuite</strong> <strong>for</strong> Regula<strong>to</strong>ry<br />
In<strong>for</strong>mation Management<br />
Designed <strong>to</strong> work both as standalone<br />
solutions, as well as integrated pieces,<br />
streamlining <strong>the</strong> entire product lifecycle<br />
within eRegula<strong>to</strong>ry Affairs and reducing<br />
<strong>the</strong> time <strong>to</strong> market.<br />
Supports <strong>the</strong> critical relationship between<br />
industry and authorities by ensuring<br />
a compliant and efficient product registration<br />
and maintenance process.<br />
Rapidly deployed and installed, validation<br />
& training take minimal time. The<br />
user interface is intuitive, fur<strong>the</strong>r reducing<br />
time <strong>to</strong> implementation.<br />
Integrates with leading technology plat<strong>for</strong>ms<br />
from vendors such as Microsoft,<br />
EMC, BIOVIA / QUMAS, MasterControl,<br />
NextDocs, OpenText, Optimal Systems<br />
or Veeva which greatly reduces <strong>the</strong> <strong>to</strong>tal<br />
cost of ownership.<br />
Currently <strong>the</strong> only Regula<strong>to</strong>ry In<strong>for</strong>mation<br />
Management System (RIMS) including a<br />
Drug Safety solution. Pharmacovigilance<br />
will become a major component within<br />
<strong>the</strong> upcoming IDMP regulation<br />
EXTEDO<br />
RIMS Vision<br />
(Cloud & in-house)<br />
Registration<br />
Management<br />
Submission Management<br />
& Publishing<br />
Submission<br />
Validation<br />
Submission Viewing<br />
& Reviewing<br />
Pharmacovigilance<br />
Management<br />
Planning & Tracking<br />
(P & T)<br />
Product Dictionary<br />
MPDviewer<br />
MPDmanager<br />
Supports:<br />
XEVMPD, IDMP<br />
Application & Publishing<br />
eCTDmanager<br />
DOCmanager<br />
RLPmanager<br />
miniDMS<br />
PlantOS 3<br />
Supports:<br />
eCTD, ASMF & DMF,<br />
NeeS, vNeeS, eCopy,<br />
CADDY-xml, …<br />
Industry<br />
EURSvalida<strong>to</strong>r<br />
Supports:<br />
US, EU, CH, ZA,<br />
GCC, CA, JP, …<br />
Health Authorities<br />
EURS<br />
Industry<br />
eCTDwebview<br />
Supports:<br />
eCTD, ASMF & DMF,<br />
NeeS, vNeeS, eCopy,<br />
CADDY-xml, …<br />
Drug Safety Database<br />
PcVmanager<br />
Supports:<br />
E2B (R2), E2B (R3)<br />
Activity P & T<br />
P&Tmanager<br />
HA Commitment &<br />
Communication<br />
Content P & T<br />
SCPmanager<br />
DOCmanager<br />
ECM & DMS Connec<strong>to</strong>rs<br />
IDMP & Corporate Master Data Management<br />
Integration via Standard APIs<br />
Gateways<br />
BIOVIA / QUMAS<br />
EMC<br />
MasterControl<br />
Microsoft<br />
SharePoint<br />
NextDocs<br />
OpenText<br />
Optimal Systems<br />
Veeva Vault<br />
…<br />
Product Dictionary<br />
(external)<br />
Product Labeling<br />
ERP System<br />
LIMS<br />
EDC<br />
…<br />
E2B (XEVMPD,<br />
ICSR, PSUR,<br />
SUSAR, …)<br />
EMA & NCAs<br />
eSubmission (CP)<br />
…
Products within <strong>the</strong> <strong>EXTEDOsuite</strong><br />
Registration<br />
Management<br />
Submission Viewing<br />
& Reviewing<br />
MPDmanager<br />
MPDmanager is EXTEDO’s comprehensive<br />
XEVMPD data base system<br />
and <strong>the</strong> integral part of <strong>the</strong> <strong>EXTEDOsuite</strong>.<br />
It provides <strong>the</strong> functionality of a central<br />
product data reposi<strong>to</strong>ry and enables you<br />
<strong>to</strong> manage and maintain XEVMPD data<br />
efficiently and in compliance with current<br />
regula<strong>to</strong>ry requirements.<br />
MPDviewer<br />
MPDviewer is a free of charge<br />
web based application. It enables you <strong>to</strong><br />
get your XEVMPD data records back from<br />
EVWEB, evaluate data, and generate reports.<br />
Submission Management<br />
& Publishing<br />
eCTDmanager<br />
eCTDmanager enables you <strong>to</strong><br />
build, view, validate and publish compliant<br />
submissions based on CTD, eCTD, NeeS,<br />
eCopy, IMPD, CTA, VNeeS, DMF, ASMF<br />
and o<strong>the</strong>r submission structures easily.<br />
PlantOS<br />
EXTEDO PlantOS 3 is an off-<strong>the</strong>shelf<br />
solution <strong>for</strong> regula<strong>to</strong>ry affairs in Crop<br />
Sciences that manages <strong>the</strong> assembly and<br />
compilation of electronic dossiers. The<br />
standards e-PRISM (USA) e-Index (CAN)<br />
CADDY.xml (EU) are supported.<br />
Submission<br />
Validation<br />
EURSvalida<strong>to</strong>r<br />
EURSvalida<strong>to</strong>r supports you in<br />
validating medicinal and veterinary eSubmissions.<br />
The valida<strong>to</strong>r is used by <strong>the</strong><br />
majority of European National Authorities<br />
including EMA <strong>to</strong> ensure eCTD and NEES<br />
compliance. EURSvalida<strong>to</strong>r is available in<br />
several versions with different functionality<br />
and validation sets.<br />
EURSvalida<strong>to</strong>r Global<br />
EURSvalida<strong>to</strong>r Global is an add-on<br />
<strong>for</strong> EURSvalida<strong>to</strong>r that provides enhanced<br />
functionality and additional validation sets.<br />
EURS<br />
EURS serves as a complete eCTD<br />
validation and reviewing software solution.<br />
It reports whe<strong>the</strong>r a submitted eCTD- or<br />
NeeS-based application con<strong>for</strong>ms <strong>to</strong> <strong>the</strong><br />
official <strong>for</strong>mat.<br />
Pharmacovigilance<br />
Management<br />
PcVmanager<br />
PcVmanager is a drug safety management<br />
software solution based on <strong>the</strong><br />
E2B and MedDRA industry data standards,<br />
that enables you <strong>to</strong> classify, create, review,<br />
submit, and maintain pharmacovigilance<br />
data and Adverse Event reports.<br />
DOCmanager<br />
DOCmanager is an add-on <strong>for</strong><br />
eCTDmanager that allows <strong>the</strong> creation and<br />
maintenance of many child dossiers based<br />
on one parent dossier and reduces update<br />
times <strong>for</strong> variations.<br />
RLPmanager<br />
RLPmanager is EXTEDO’s advanced<br />
solution <strong>for</strong> report level publishing;<br />
it has been designed <strong>to</strong> optimize prepublishing<br />
work and support clinical study<br />
departments in managing and preparing<br />
study reports by au<strong>to</strong>mated processes.<br />
RLPmanager provides <strong>the</strong> environment<br />
and functionality <strong>for</strong> creation, compilation,<br />
validation and publishing of clinical and<br />
nonclinical study reports that later become<br />
part of eCTD or NeeS submissions.<br />
About us<br />
EXTEDO is <strong>the</strong> key software and service<br />
solutions provider in <strong>the</strong> field of Regula<strong>to</strong>ry<br />
In<strong>for</strong>mation Management (RIM). EXTEDO’s<br />
focus is on optimizing clients’ eRegula<strong>to</strong>ry<br />
business processes. The company’s<br />
enabling technology, <strong>the</strong> <strong>EXTEDOsuite</strong>,<br />
is unique in that it covers <strong>the</strong> complete<br />
regula<strong>to</strong>ry landscape including: product<br />
registration planning & tracking (IDMP),<br />
submission management, pharmacovigilance<br />
management and document management.<br />
Today, EXTEDO serves over 700<br />
cus<strong>to</strong>mers in 60 countries, including <strong>the</strong><br />
EMA and more than 25 regula<strong>to</strong>ry authorities<br />
worldwide.<br />
www.extedo.com<br />
EXTEDO GmbH<br />
Einsteinstraße 30<br />
85521 Ot<strong>to</strong>brunn / GER<br />
Phone: +49 (89) 189454-0<br />
Fax: +49 (89) 189454-999<br />
EXTEDO, Inc.<br />
1235 Westlakes Dr., Suite 285<br />
Berwyn, PA 19312 / USA<br />
Phone: +1 (855) 328 3500<br />
Fax: +1 (610) 240 9301<br />
14/09<br />
E-mail: info@extedo.com<br />
Internet: www.extedo.com