All prices in US dollars. Demos available on request [Contact] |
Authoring Tool + Document Inventory |
DocTemplate © Authoring Tool
for Word 93-2003
DocTemplate © Authoring Tool
for Word 2007 |
An MS Word Add-in that complements our templates and facilitates the creation of multipurpose documents for CTD and eCTD submissions.
Bundled free with purchase of full set of templates. |
2200 |
Document Inventory |
Document Inventory: Module 1-5
A complete inventory of submission documents:
Modules 1 - 5. [Excel spreadsheet format] |
NC
[with full set] |
CTD Submission Templates |
Module 1 – USA |
IND Annual Report US M1 Templates [14 files] |
500 |
NDA Annual Report_US M1_Templates [12 files] |
500 |
Module 1 – Canada |
RA Product Monograph |
250 |
Module 1 - EU |
141_Information about the Expert Quality
142_Information about the Expert Non Clinical
143_Information on the Expert Clinical EU |
NC
[with full set] |
SPC - Summary of Product Characteristics |
250 |
Module 2 – Clinical |
Templates for Clinical Overview and Clinical Summary [9 files] |
700 |
Module 2 – Non Clinical |
Templates for Non Clinical Overview and Non Clinical Written Summary [8 files] |
1000 |
Module 2 - Quality |
Templates for Quality Overall Summary [20 files] |
300 |
Module 3 - References |
33 References [included with purchase of Module 3 templates] |
0 |
Module 3 – Drug Substance |
Templates for Section 3.2.S [22 files] |
1500 |
Module 3 – Drug Product |
Templates for Section 3.2.P [24 files] |
1500 |
Module 3 - Appendices |
Templates for Sections 3A and 3R [ 6 files]
[included with purchase of Module 3 templates]] |
0 |
Module 3 – Stability Report |
Template for Stability Report |
350 |
Module 4 - NCRR |
Template for Non Clinical Research Report |
350 |
Module 5 - IB |
Template for Investigators Brochure |
350 |
Module 5 - Protocol |
Template for Clinical Protocol |
350 |
Module 5 - CSR |
Template for Clinical Study Report |
350 |
Module 5 - CSRS |
Template for Clinical Study Report Synopsis [included with CSR] |
0 |
Module 5 - CA |
Templates for Clinical Appendices [16 files] |
500 |
Module 5 - TL |
5.2 Template for Tabular Listing of Clinical Studies |
NC |
Standard Operating Procedures (SOPs) |
SOP Core Template |
350 |
Authoring and Managing Documents |
350 |
Development and Management of Documents Prepared by Contract Research Organizations_2007 |
350 |
Preparation and Change Control of SOPs |
350 |
Procedure for Review, Approval & Finalization of Documents in EDMS |
350 |
Submission and Document Archiving Procedure |
350 |
Guides |
DocTemplate Specification and User Guide [included with purchase] |
0 |
Template and Style Guide [included with purchase] |
0 |
