Release Configuration - LORENZ Life Sciences Group

Release Configuration
Version 5.10.1.02
March 2018
© LORENZ Life Sciences Group
Release Configuration Version 5.10.1.02
Table of Contents
1.
About this document....................................................................................................... 5
1.1
2.
Notes ...................................................................................................................... 5
Where this software should be installed ......................................................................... 6
2.1
Notes for installations in a validated environment .................................................... 6
2.2
Installation Qualification (IQ) ................................................................................... 6
3.
List of documentation deliverables ................................................................................. 7
4.
Software Installation Package ........................................................................................ 8
5.
4.1
eValidator Workstation ............................................................................................ 8
4.2
eValidator configPanel ............................................................................................ 8
Release Notes................................................................................................................ 9
5.1
Target Platform Information ..................................................................................... 9
5.2
Hardware requirements information ........................................................................ 9
5.3
Release compatibility information ...........................................................................10
5.4
Setup .....................................................................................................................11
5.5
License Types ........................................................................................................11
5.5.1
eValidator Basic license ..................................................................................11
5.5.2
eValidator ONE license ...................................................................................11
5.5.3
eValidator Enterprise license ...........................................................................12
5.5.4
New/Update Installation ..................................................................................12
5.6
eValidator Workstation: Changes in Release 5.10.1.02 ..........................................16
5.6.1
5.7
Priority CRITICAL............................................................................................16
eValidator Workstation: Changes in Release 5.10.1.01 ..........................................19
5.7.1
Priority CRITICAL............................................................................................19
Release Configuration Version 5.10.1.02
Disclaimer
© 2018 LORENZ Life Sciences Group
All rights reserved in whole or in part and in all forms of media throughout the world. Any
rights not expressly granted herein are expressly reserved by LORENZ Life Sciences Group.
All information and articles in this document are covered by copyright law. Articles and
documents contained in this document are the copyright of LORENZ Life Sciences Group.
Any commercial reproduction of any material included here is expressly prohibited.
Except as stated above, no part of this document may be reproduced, stored in a retrieval
system, or transmitted in any form, or by any means, electronic, mechanical, photocopying,
recording or otherwise, without prior written permission of LORENZ Life Sciences Group, or
the respective copyright owner.
Copyright includes the use of any underlying hypertext markup used in the creation of this
document.
All trademarks, service marks and logos (trademarks) of companies and products mentioned
or used in this document are the property of their respective owners.
Trademarks
The following trademarks of other companies may appear in this document:
Microsoft is a registered trademark of Microsoft Corporation in the United States and/or other
countries.
Microsoft Windows, Microsoft Windows 7, Microsoft Windows 8, and Microsoft Windows 10
are registered trademarks or trademarks of Microsoft Corporation in the United States and/or
other countries.
Acrobat is a trademark of Adobe Systems Incorporated.
All other names of products or companies mentioned in this document are trademarks or
registered trademarks of their respective owner.
© LORENZ Life Sciences Group
3
Release Configuration Version 5.10.1.02
Revision History
Revision
Date
Modifier
Description
1.00
03-Mar-2018
J. Wermusch
Initial version
1.01
18-Mar-2018
J. Wermusch
Description text updated for EVA-1829
1.02
18-Mar-2018
J. Wermusch
Added release notes from 5.10.1.01
© LORENZ Life Sciences Group
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Release Configuration Version 5.10.1.02
1. About this document
This document contains the configuration details, the release notes and additional
information for LORENZ eValidator 5.10.1.02, including:
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1.1
The content of the new shipment.
Compatibility with other components.
Installation instructions.
Notes
Throughout this document:
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The phrase eValidator refers to the LORENZ eValidator product.
The phrase installation folder refers to the folder where the eValidator has been or
shall be installed to (this is usually the folder named C:\Program Files\LORENZ
Life Sciences\LORENZ eValidator).
The phrase configuration folder refers to the folder where the eValidator configuration
files have been or shall be installed to (this is the sub-folder named LORENZ Life
Sciences\Automator in the CommonAppData folder.
The folder referred to by CommonAppData is C:\ProgramData.
© LORENZ Life Sciences Group
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Release Configuration Version 5.10.1.02
2. Where this software should be installed
This software release can be installed on both client and server computers. It may be used
side by side with the docuBridge client, and also with LORENZ Automator.
2.1
Notes for installations in a validated environment
According to the implemented change control procedures, (re-)validation steps will be
required when putting the application into operational use. This depends on the validation
policy implemented at the customer site.
LORENZ strongly suggests performing Installation Qualification (IQ), Operational
Qualification (OQ) and Performance Qualification (PQ) based on a Validation Plan (VP). In
addition, a thorough risk analysis and risk controlling should be performed.
The eValidator does not store or modify any electronic records for electronic submissions.
However, due to the importance of correctness for the validation results, LORENZ
recommends (re-)validating the product.
For validated environments:
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•
2.2
The software validation impact notes given in in this document only apply for
customers upgrading from an existing 5.x release. All other customers should
consider performing a full validation according to the policy defined in the
organization.
The tables with the change impact information can be used to evaluate the option to
deploy new or changed features without installing the new version with the setup. For
example, if just some profiles have been changed to resolve an issue or provide a
new feature, but no other files (code or configuration) are affected, it is safe to just
copy the new or modified profiles from the “unpacked” setup folder to an already
existing installation. By doing this, customers should adjust their system validation
documentation accordingly. If you are not sure whether you can just copy some files
instead of running the setup, please contact LORENZ for assistance.
Installation Qualification (IQ)
Both the setup package and the software binaries have been signed electronically to comply
with the new security guidelines on Windows Server 2008, Windows Server 2012, and
Windows 7, 8, or 10. The LORENZ certificate has been issued by GlobalSign
(www.globalsign.com). If you need additional details about the certificate used, please
contact LORENZ support.
Please only install LORENZ Automator software that has a genuine electronic signature
issued to LORENZ Bridge Software GmbH. The signature will be shown upon installation.
© LORENZ Life Sciences Group
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Release Configuration Version 5.10.1.02
3. List of documentation deliverables
The distribution of release 5.10.1.02 for eValidator contains the following documentation:
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This Release Configuration document
The Functional Specification document from version 5.10.1
User Guide documentation for LORENZ eValidator 5.10.1
© LORENZ Life Sciences Group
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Release Configuration Version 5.10.1.02
4. Software Installation Package
The distribution contains the software setup for eValidator 5.10.1.02. The setup can be used
for both new and upgrade installations.
The setup is provided as a full setup. It does not require any previous installation. If a
previous version of the LORENZ eValidator is found during installation, it will be updated.
This distribution does not contain a new setup for the eValidator webPanel. You can still use
eValidator webPanel version 5.10.1.
4.1
eValidator Workstation
This application allows verifying and validating electronic submissions purposely conforming
to the ICH eCTD standard (see www.ich.org) based on configured check options and
dynamic verification rules. Validation results will be created as XML and as HTML reports;
adequate XSL style sheets for viewing the report content in a web browser are also provided.
LORENZ will periodically provide updates for the configuration base to keep the eValidator
synchronized with the official specifications.
The eValidator also supports validating certain non-eCTD submissions (NeeS and VNeeS).
For details about the predefined validation rules for non-eCTD submissions, please refer to
the user guide or the Functional Specification (FSP).
4.2
eValidator configPanel
This tool can be used by administrators to configure the LORENZ eValidator system. It will
only be installed if the Workflow Service feature has been selected. The eValidator
configPanel provides the following features and functions:
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Comprehensive configuration settings management
License management
Log file examination
Start and stop the Workflow Service
Detailed version information
System configuration validation
Importing and exporting system snapshots
© LORENZ Life Sciences Group
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Release Configuration Version 5.10.1.02
5. Release Notes
5.1
Target Platform Information
The application has been tested and certified for the following operating system platforms:
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Microsoft Windows 7 (32 and 64 Bit)
Microsoft Windows 7 SP1 (32 and 64 Bit)
Microsoft Windows 8 (32 and 64 Bit)
Microsoft Windows 8.1 (32 and 64 Bit)
Microsoft Windows 10
Microsoft Windows Server 2008 R2 (including SP1)
Microsoft Windows Server 2012
Microsoft Windows Server 2012 R2
Microsoft Windows Server 2016
The application setup requires Microsoft Windows Installer 3.1, which will be installed
automatically if not already existing on the target computer.
All components are native Microsoft .NET 4.6.2 assemblies. Therefore, the .NET 4.6.2
runtime is required to use the applications. The setup will not automatically install the .NET
framework if not already present on the target computer. You need to do this manually before
you start the installation of the eValidator.
5.2
Hardware requirements information
Minimum system
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1 GHz processor
1 GB RAM
100 GB HDD
Recommended system
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2 GHz processor with 2 or more cores or a multi-processor system
4 GB RAM
100 GB HDD
© LORENZ Life Sciences Group
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Release Configuration Version 5.10.1.02
5.3
Release compatibility information
There are no compatibility issues for eValidator 5.10.1.02 related to previous versions.
This version will automatically replace an existing previous version of LORENZ eValidator 5
found on the computer when you install LORENZ eValidator 5.10.1.02. Any version before
LORENZ eValidator 5.0 will not be removed or upgraded by the eValidator setup. If you want
to remove such a previous version, you need to uninstall it manually via the Add/Remove
Programs dialog in the Control Panel or by re-running the setup program that installed the
version.
The setup will install the eValidator only. Since version 5.8.1, the LORENZ Automator is now a
self-contained product, which needs to be installed separately.
© LORENZ Life Sciences Group
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Release Configuration Version 5.10.1.02
5.4
Setup
Prior to installing eValidator, please unzip the distribution files to a temporary directory. If you
have received the product on a CD or DVD, please copy the files to a temporary location on
a hard disk and remove the “read-only” flags of these files before you continue.
The setup is provided as a full setup. It does not require any previous installation. If a
previous version of the LORENZ eValidator is found during installation, it will be updated.
5.5
License Types
For the LORENZ eValidator different license types are available:
5.5.1 eValidator Basic license
This is a free of charge license which allows running validations for eCTD or non-eCTD
submissions. Several features have been disabled for this license type:
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You cannot use customized profiles or change the report branding text and logo.
Using the LORENZ eValidator Batch Processing is not supported.
Only English localization is available.
You cannot create or use custom profiles.
You cannot change any severity settings for the validation rules.
You cannot change any rule parameters in a loaded profile.
You cannot change the profile you have selected on first start of the software. Only
reinstalling the software will allow re-selecting the profile.
If you are using a “branded” version of the eValidator (such as BfArM eValidator or
AGES eValidator), changing the profile is limited to the EU related profiles.
You cannot validate submissions on a server operating system such as Microsoft
Windows Server 2008 or 2012.
The eValidator PowerShell host is not supported.
You will not get the summary report in addition to the full validation report.
You cannot use parallel execution of validation rules to improve the overall
performance for large submissions.
Profile content reports are not available.
You cannot use “Baseline Optimized Validation”.
You cannot use the automated profile update feature.
5.5.2 eValidator ONE license
This license provides the same features as the Basic version plus the option to switch
between profiles (regions) without reinstalling the software. The other limitations of the Basic
license are still effective.
The license can be purchased online at http://www.lorenz.cc/eSolutions/eValidator.
© LORENZ Life Sciences Group
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Release Configuration Version 5.10.1.02
5.5.3 eValidator Enterprise license
This license does not have the functional limitations of the eValidator Basic or eValidator
ONE license. Please note that the available extended profiles may depend on the modules
you purchased. Additional features (e.g. the webPanel) can be purchased separately for this
license type. For detailed information please contact LORENZ sales or talk to your LORENZ
representative.
5.5.4 New/Update Installation
There are two different setup packages available:
5.5.4.1 Standard LORENZ setup, compressed
Start the setup.msi to install the software.
5.5.4.2 Standard LORENZ setup, unpacked
This setup consists of multiple files, including a setup.msi. Start the setup.msi to install the
software. You can customize this package before deploying it on your site. For example, you
can add the license serial number to the system.config file in the package before deploying
the package.
While it does not matter which setup (compressed or unpacked) you are using to update an
existing previous product version or to install it for the first time, you must use the same setup if
you want to uninstall or modify it later. Otherwise, uninstalling it will not work and when trying to
modify an installation you would end up with two copies of the product installed.
Before installing LORENZ eValidator, please unzip the distribution file to a temporary
directory. If you have received the product on a CD or DVD, please copy the files to a
temporary location on a hard disk and remove the file’s “read-only” flags before you continue.
Now follow these steps to perform the installation:
1. In case Windows Installer (3.1 or higher) and/or Microsoft .NET 4.6.2 runtime are
not already present, these components will not be installed first. You need to do this
manually before you start the installation of the eValidator.
2. Navigate to the setup folder Setup LORENZ eValidator.
3. Start the file setup.msi.
4. Acknowledge the confirmation dialogs and follow the instructions on the screen.
Completing the installation of these components might require restarting the
computer.
5. The eValidator installation wizard will be started. On Windows 7, Windows 8,
Windows 10, Windows Server 2008, 2012, and 2016, you will get a confirmation
message like the one in the following picture showing the publishers identity:
© LORENZ Life Sciences Group
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Release Configuration Version 5.10.1.02
6. To protect you from fraud through tampered software packages, please
acknowledge this message only if the verified publisher is LORENZ Bridge Software
GmbH. You can click on Show details to see additional information about the
publisher's identity.
7. Follow the instructions displayed to complete the installation. For a quick and easy
procedure, it is recommended to accept the default settings provided by the wizard.
8. A new desktop shortcut (LORENZ eValidator) and a new start
menu item will be created (LORENZ Life Sciences\eValidator).
Both shortcuts can be used to start the application.
9. Start the eValidator. You will now be asked to select a profile for
validation.
© LORENZ Life Sciences Group
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Release Configuration Version 5.10.1.02
Profiles contain collections of validation rules and settings for a specific validation scope (e.g.
submitting an application to the FDA or to Health Canada).
The LORENZ eValidator installs a set of different profiles you can choose from. However,
with the Basic license, a profile once chosen cannot be changed without reinstalling the
software. This applies to all users on a single computer (i.e. the profile chosen by the user
who ran the application first will be applied to all other users as well and cannot be changed
© LORENZ Life Sciences Group
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Release Configuration Version 5.10.1.02
without reinstalling the software). The Enterprise version and the eValidator ONE versions do
not have this limitation. To choose a profile, double-click the corresponding line or select the
line and click the OK button. The profile will be loaded. The next time you start the LORENZ
eValidator, you will not be prompted for the profile again; it will be loaded automatically.
© LORENZ Life Sciences Group
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Release Configuration Version 5.10.1.02
5.6
eValidator Workstation: Changes in Release 5.10.1.02
5.6.1 Priority CRITICAL
5.6.1.1 EVA-1828 – EU eCTD Validation: Rule 14.4
Description
When validating an EU eCTD submission, the eValidator does not always report a missing
country specific envelope (validation criterion 14.4). The problem was caused by an incorrect
comparison of the country values in the country specific leaf elements with the corresponding
country values in the envelopes. The comparison results differed if the order of the envelope
element was changed.
This has now been resolved.
Ticket Evaluation
Priority
Critical
Type
Bug
Item
Change Impact
Profiles
EU eCTD M1 3.0.2 - Validation Criteria 6.1
EU eCTD M1 3.0.2 - Validation Criteria 6.1, Extended
Configuration Files
No changes.
Program Code
No changes.
Documentation
No changes.
Validation Impact
Description
IQ
n/a
OQ
n/a
PQ
Customers with EU eCTD submissions, which include country specific leaf elements,
should verify that the rule is now working properly.
Rule 14.4
Rule 14.4
Sample scenario that was not detected with the previous version of the eValidator:
Order of country specific envelopes: at, be, el, es
Country specific leaf elements in m1-0-cover: be, ee, es, at, el
The missing envelope for “ee” was not reported previously.
© LORENZ Life Sciences Group
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Release Configuration Version 5.10.1.02
5.6.1.2 EVA-1829 - TGA AU NeeS v3.1: Rule 4.1.1
Description
When validating an AU NeeS 3.1 submission sequence, missing mandatory elements in the
envelope were not reported by rule 4.1.1.
This has now been corrected: The rule will now perform a full validation of the envelope
before proceeding with the other envelope checks. This includes both the presence and the
order of elements in the envelope.xml file, in exactly the same way as it will be checked for
an eCTD submission. A failed validation will result in an error and the envelope will not be
processed further.
Please note: Envelopes generated through the Excel file posted on the TGA web site will
always be technically valid. The problem only applies to manually generated envelope files
(e.g. using a text editor).
Furthermore, the name of the eValidator file will now accept the envelope file with and
without a variable part: envelope-var.xml. Previously only evelope.xml was considered a
valid name for the envelope file.
Ticket Evaluation
Priority
Critical
Type
Bug
Item
Change Impact
Profiles
AU NeeS - Val. Crit. 3.1
AU NeeS - Val. Crit. 3.1, EXTENDED
Configuration Files
Changed.
Program Code
Changed.
Documentation
No changes.
Validation Impact
Description
IQ
n/a
OQ
n/a
PQ
Recommended validation script updates:
In an AU NeeS v3.1 submission, provide an envelope.xml file that:
- Misses one or more mandatory elements (e.g. esub-id, product-name).
- Contains additional (undefined) elements
© LORENZ Life Sciences Group
Rule 4.1.1
Rule 4.1.1
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Release Configuration Version 5.10.1.02
Validation Impact
Description
- Contains elements in an incorrect order
All three cases listed above should be reported as errors by rule 4.1.1.
© LORENZ Life Sciences Group
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Release Configuration Version 5.10.1.02
5.7
eValidator Workstation: Changes in Release 5.10.1.01
5.7.1 Priority CRITICAL
5.7.1.1 EVA-1785 – CA HC Non-eCTD 4.2 Profile: Rule A08
Description
The valid file extensions for documents in a non-eCTD submission for Health Canada are
checked in rule A08. The file types in the eValidator profile differ from those on the Health
Canada web site (please see here). This is because the eValidator profile uses the originally
posted file types as of July 28, 2017. In September 2017, Health Canada has updated the file
types list on the web site.
The profile has now been updated. The file types that have been added to the profiles are tif,
tiff, bmp, sas, and xpt.
Ticket Evaluation
Priority
Critical
Type
Bug
Item
Change Impact
Profiles
CA Non-eCTD - Validation Criteria 4.2
CA Non-eCTD - Validation Criteria 4.2, Extended
Configuration Files
No changes.
Program Code
No changes.
Documentation
No changes.
Validation Impact
Description
IQ
n/a
OQ
n/a
PQ
Customers with non-eCTD submissions to Health Canada should verify that the
updated profiles now accept the file types as posted on the HC web site. In previous
versions of the eValidator, the file types tif, tiff, bmp, sas, and xpt were incorrectly
reported as invalid.
© LORENZ Life Sciences Group
Rule A08
Rule A08
19
Release Configuration Version 5.10.1.02
5.7.1.2 EVA-1797 - TGA AU eCTD M1 v3.1: Incorrect Results for Rule 4.2.11
Description
When validating an AU eCTD M1 3.1 submission sequence that relates to a sequence with
previous schema version 3.0, the eValidator always reported an error at 4.2.11. However, the
rule 4.2.11 should only compare the submission mode against the one used in the related
sequence if both current and related sequence are using schema version 3.1.
This has now been corrected.
Ticket Evaluation
Priority
Critical
Type
Bug
Item
Change Impact
Profiles
AU eCTD - Val. Crit. 3.1
AU eCTD - Val. Crit. 3.1, EXTENDED
Configuration Files
No changes.
Program Code
No changes.
Documentation
No changes.
Validation Impact
Description
IQ
n/a
OQ
n/a
PQ
Recommended validation script updates:
- Create a submission sequence A with AU M1 v3.1 that references a
related sequence B, which was created as an AU M1 v3.0 submission.
- Validate sequence A and verify that rule 4.2.11 does not report an error if
both sequence A and sequence B have the same submission mode
value set.
© LORENZ Life Sciences Group
Rule 4.2.11
Rule 4.2.11
20
Release Configuration Version 5.10.1.02
5.7.1.3 EVA-1799 – CA HC eCTD 4.3 Profile: Rule B46
Description
The implementation for rule B46 in the eCTD validation profile for Canadian submissions was
incorrect. It should check for the document restriction “Content Copying” only. However, it
incorrectly also checked for the document restriction “Document Assembly”, which led to
false positives for the HC application forms, for example.
This has now been corrected.
Ticket Evaluation
Priority
Critical
Type
Bug
Item
Change Impact
Profiles
CA eCTD - Val. Crit. 4.3
CA eCTD - Val. Crit. 4.3 EXTENDED
Configuration Files
No changes.
Program Code
No changes.
Documentation
No changes.
Validation Impact
Description
IQ
n/a
OQ
n/a
PQ
Recommended validation script updates:
- Validate a CA eCTD submission and check the results for B46. It should
not report any of the HC application forms as being incorrectly protected.
© LORENZ Life Sciences Group
Rule B46
Rule B46
21
Release Configuration Version 5.10.1.02
5.7.1.4 EVA-1805 – TGA AU NeeS v3.1: Incorrect Results for Rule 4.1.1
Description
When validating an AU NeeS 3.1 submission, a missing envelope.xml will be reported as an
error. However, an invalid envelope.xml (e.g. root element incorrect or missing) was not
reported as an error.
This has now been corrected.
Ticket Evaluation
Priority
Critical
Type
Bug
Item
Change Impact
Profiles
AU NeeS - Validation Criteria 3.1
AU NeeS - Validation Criteria 3.1, EXTENDED
Configuration Files
No changes.
Program Code
No changes.
Documentation
No changes.
Validation Impact
Description
IQ
n/a
OQ
n/a
PQ
Recommended validation script updates:
- Validate an AU NeeS 3.1 submission, with an envelope.xml file that
misses the required root element au-nees-envelope.
- An error message must be reported for 4.1.1 that the envelope.xml file is
missing or invalid.
© LORENZ Life Sciences Group
Rule 4.1.1
Rule 4.1.1
22
Release Configuration Version 5.10.1.02
© LORENZ Life Sciences Group
23
LORENZ Life Sciences Group
Internet: www.lorenz.cc | E-Mail: www.lorenz.cc/email
LORENZ Archiv-Systeme GmbH
LORENZ Life Sciences Ltd.
LORENZ Polska
Eschborner Landstrasse 75
60489 Frankfurt/Main
GERMANY
No. 1 Farnham Road
Guildford, Surrey GU2 4RG
UNITED KINGDOM
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ul Grójecka 22/24/4
Warsaw 02-301
POLAND
Tel
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Tel
Fax
Tel
Fax
+49 69 78 991-901
+49 69 78 991-129
+44 14 83 903 861
+44 20 76 812 676
LORENZ International LLC
LORENZ Newbook Inc.
1515 Market Street, Suite 1200
Philadelphia, PA 19102
USA
2355 Derry Road East, Unit 39
Mississauga, Ontario, L5S 1V6
CANADA
Tel
Tel
Fax
+1 866 9567 369
+1 866 9LORENZ
+1 866 2956 967
+1 905 6709 997
+1 800 5889 334
LORENZ Life Sciences India Pvt Ltd.
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No: 01, Sidco Industrial Estate
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Chennai-600 032
INDIA
Tsukiji No. 1
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Tsukiji, Chuo-ku, Tokyo 104 - 0045
JAPAN
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