5 Reasons to choose the EXTEDOsuite for Regulatory Information ...

The EXTEDOsuite as seen below 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.
5 Reasons to choose the
EXTEDOsuite for Regulatory
Information Management
Designed to work both as standalone
solutions, as well as integrated pieces,
streamlining the entire product lifecycle
within eRegulatory Affairs and reducing
the time to market.
Supports the critical relationship between
industry and authorities by ensuring
a compliant and efficient product registration
and maintenance process.
Rapidly deployed and installed, validation
& training take minimal time. The
user interface is intuitive, further reducing
time to implementation.
Integrates with leading technology platforms
from vendors such as Microsoft,
EMC, BIOVIA / QUMAS, MasterControl,
NextDocs, OpenText, Optimal Systems
or Veeva which greatly reduces the total
cost of ownership.
Currently the only Regulatory Information
Management System (RIMS) including a
Drug Safety solution. Pharmacovigilance
will become a major component within
the upcoming IDMP regulation
EXTEDO
RIMS Vision
(Cloud & in-house)
Registration
Management
Submission Management
& Publishing
Submission
Validation
Submission Viewing
& Reviewing
Pharmacovigilance
Management
Planning & Tracking
(P & T)
Product Dictionary
MPDviewer
MPDmanager
Supports:
XEVMPD, IDMP
Application & Publishing
eCTDmanager
DOCmanager
RLPmanager
miniDMS
PlantOS 3
Supports:
eCTD, ASMF & DMF,
NeeS, vNeeS, eCopy,
CADDY-xml, …
Industry
EURSvalidator
Supports:
US, EU, CH, ZA,
GCC, CA, JP, …
Health Authorities
EURS
Industry
eCTDwebview
Supports:
eCTD, ASMF & DMF,
NeeS, vNeeS, eCopy,
CADDY-xml, …
Drug Safety Database
PcVmanager
Supports:
E2B (R2), E2B (R3)
Activity P & T
P&Tmanager
HA Commitment &
Communication
Content P & T
SCPmanager
DOCmanager
ECM & DMS Connectors
IDMP & Corporate Master Data Management
Integration via Standard APIs
Gateways
BIOVIA / QUMAS
EMC
MasterControl
Microsoft
SharePoint
NextDocs
OpenText
Optimal Systems
Veeva Vault
…
Product Dictionary
(external)
Product Labeling
ERP System
LIMS
EDC
…
E2B (XEVMPD,
ICSR, PSUR,
SUSAR, …)
EMA & NCAs
eSubmission (CP)
…

Products within the EXTEDOsuite
Registration
Management
Submission Viewing
& Reviewing
MPDmanager
MPDmanager is EXTEDO’s comprehensive
XEVMPD data base system
and the integral part of the EXTEDOsuite.
It provides the functionality of a central
product data repository and enables you
to manage and maintain XEVMPD data
efficiently and in compliance with current
regulatory requirements.
MPDviewer
MPDviewer is a free of charge
web based application. It enables you to
get your XEVMPD data records back from
EVWEB, evaluate data, and generate reports.
Submission Management
& Publishing
eCTDmanager
eCTDmanager enables you to
build, view, validate and publish compliant
submissions based on CTD, eCTD, NeeS,
eCopy, IMPD, CTA, VNeeS, DMF, ASMF
and other submission structures easily.
PlantOS
EXTEDO PlantOS 3 is an off-theshelf
solution for regulatory affairs in Crop
Sciences that manages the assembly and
compilation of electronic dossiers. The
standards e-PRISM (USA) e-Index (CAN)
CADDY.xml (EU) are supported.
Submission
Validation
EURSvalidator
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. EURSvalidator is available in
several versions with different functionality
and validation sets.
EURSvalidator Global
EURSvalidator Global is an add-on
for EURSvalidator that provides enhanced
functionality and additional validation sets.
EURS
EURS serves as a complete eCTD
validation and reviewing software solution.
It reports whether a submitted eCTD- or
NeeS-based application conforms to the
official format.
Pharmacovigilance
Management
PcVmanager
PcVmanager is a drug safety management
software solution based on the
E2B and MedDRA industry data standards,
that enables you to classify, create, review,
submit, and maintain pharmacovigilance
data and Adverse Event reports.
DOCmanager
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.
RLPmanager
RLPmanager is EXTEDO’s advanced
solution for report level publishing;
it has been designed to optimize prepublishing
work and support clinical study
departments in managing and preparing
study reports by automated processes.
RLPmanager provides the environment
and functionality for creation, compilation,
validation and publishing of clinical and
nonclinical study reports that later become
part of eCTD or NeeS submissions.
About us
EXTEDO is the key software and service
solutions provider in the field of Regulatory
Information Management (RIM). EXTEDO’s
focus is on optimizing clients’ eRegulatory
business processes. The company’s
enabling technology, the EXTEDOsuite,
is unique in that it covers the complete
regulatory landscape including: product
registration planning & tracking (IDMP),
submission management, pharmacovigilance
management and document management.
Today, EXTEDO serves over 700
customers in 60 countries, including the
EMA and more than 25 regulatory authorities
worldwide.
www.extedo.com
EXTEDO GmbH
Einsteinstraße 30
85521 Ottobrunn / GER
Phone: +49 (89) 189454-0
Fax: +49 (89) 189454-999
EXTEDO, Inc.
1235 Westlakes Dr., Suite 285
Berwyn, PA 19312 / USA
Phone: +1 (855) 328 3500
Fax: +1 (610) 240 9301
14/09
E-mail: info@extedo.com
Internet: www.extedo.com