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Documents / Price List

 

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