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All prices in US dollars.
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Authoring
Tool + Document Inventory
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DocTemplateÓ Authoring Tool
for
Word 93-2003
DocTemplateÓ Authoring Tool
for
Word 2007
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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.
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2200
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Document
Inventory
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Document
Inventory: Module 1-5
A
complete inventory of submission documents:
Modules
1 - 5. [Excel spreadsheet format]
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NC
[with full set]
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CTD
Submission Templates
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Module
1 – USA
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IND
Annual Report US M1 Templates [14 files]
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500
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NDA
Annual Report_US M1_Templates [12 files]
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500
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Module
1 – Canada
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Product
Monograph
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250
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Module
1 - EU
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141
Information about the Expert Quality
142
Information about the Expert Non Clinical
143_Information
on the Expert Clinical EU
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NC
[with full set]
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SPC
- Summary of Product Characteristics
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250
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Module
2 – Clinical
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Templates
for Clinical Overview and Clinical Summary [7 files]
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700
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Module
2 – Non Clinical
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Templates
for Non Clinical Overview and Non Clinical Written Summary [8 files]
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1000
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Module
2 - Quality
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Templates
for Quality Overall Summary [20 files]
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300
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Module
3 - References
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33
References [included with purchase of Module 3 templates]
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0
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Module
3 – Drug Substance
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Templates
for Section 3.2.S [22 files]
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1500
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Module
3 – Drug Product
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Templates
for Section 3.2.P [24 files]
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1500
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Module
3 - Appendices
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Templates
for Sections 3A and 3R [ 6 files]
[included
with purchase of Module 3 templates]]
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0
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Module
3 – Stability Report
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Template
for Stability Report
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350
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Module
4 - NCRR
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Template
for Non Clinical Research Report
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350
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Module
5 - IB
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Template
for Investigators Brochure
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350
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Module
5 - Protocol
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Template
for Clinical Protocol
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350
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Module
5 - CSR
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Template
for Clinical Study Report
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350
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Module
5 - CSRS
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Template
for Clinical Study Report Synopsis [included with CSR]
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0
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Module
5 - CA
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Templates
for Clinical Appendices [16 files]
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500
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Module
5 - TL
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5.2
Template for Tabular Listing of Clinical Studies
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NC
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Standard
Operating Procedures (SOPs)
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SOP
Core Template
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350
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Authoring
and Managing Documents
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350
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Development
and Management of Documents Prepared by Contract Research
Organizations_2007
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350
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Preparation
and Change Control of SOPs
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350
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Procedure
for Review, Approval & Finalization of Documents in EDMS
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350
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Submission
and Document Archiving Procedure
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350
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Guides
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DocTemplate
Specification and User Guide [included with purchase]
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0
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Template
and Style Guide [included with purchase]
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0
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MEDICAL DEVICE
TEMPLATES
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510k
Premarket Notification
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510k Template Package
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510(k) Shell, Guidance and Applicable Templates
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2500
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EU
Technical File, Essential Requirements Checklist, Declaration of Conformity
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EU Technical File
Design Dossier
Essential Requirements Checklist
Declaration of Conformity
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EU Technical File Shell, Guidance and
Applicable Templates
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2500
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Investigational
Device Exemption (IDE)
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(PMA)
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Design
and Development Planning
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Design
& Development Plan [Form 100]
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Design
& Development Plan
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800
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Form
101 Technical Plan [Form 101]
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Technical
Plan
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800
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Quality
Plan [Form 102]
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Quality
Plan
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800
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Regulatory
Plan [Form 103]
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Regulatory
Plan
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1200
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Manufacturing
Plan [Form 104]
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Manufacturing
Plan
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800
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Service
& Support Plan [Form 105]
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Service
& Support Plan
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800
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Marketing
Plan [Form 106]
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Marketing
Plan
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800
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Risk
Management Plan [Form 107]
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Risk
Management Plan
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1200
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Design
Input
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User Requirements Document
[Form 110]
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User Requirements Document
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800
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Design Input Requirements
[Form 111]
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Design Input Requirements
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800
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Design
Output
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Manufacturing Readiness Report
[Form 120]
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Manufacturing Readiness Report
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800
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Commercialization Readiness Report
[Form 121]
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Commercialization Readiness Report
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800
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Design
Reviews
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Design Review Meeting Minutes
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Design Review Meeting Minutes
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400
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Design
Verification
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Design Verification Plan [Form 150]
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Design Verification Plan
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1200
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Design Verification Protocol
[Form 151]
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Design Verification Protocol
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400
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Design Verification Protocol Report [Form 152]
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Design Verification Protocol Report
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400
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Design Verification Report [Form 153]
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Design Verification Report
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1200
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Design
Validation
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Design Validation Plan [Form 160]
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Design Validation Plan
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1200
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Design Validation Protocol [Form 161]
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Design Validation Protocol
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400
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Design Validation Protocol Report [Form 162]
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Design Validation Protocol Report
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400
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Design Validation Report [Form 163]
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Design Validation Report
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1200
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Risk Analysis Report [Form 165]
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Risk Analysis Report
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1200
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Process Validation Plan [Form 166]
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Process Validation Plan
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800
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Process Validation Report [Form 167]
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Process Validation Report
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800
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Nonconforming Material Report [Form 019]
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Nonconforming Material Report
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800
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Corrective/Preventative Action Deviation
Report [Form 186]
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Corrective/Preventative Action Deviation
Report
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800
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Deviation Report [Form 252]
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Deviation Report
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800
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Design
History File
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Design History File Index [Form 170]
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Design History File Index
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400
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