DocTemplate Authoring Tool, eCTD Templates and Medical Device Templates
Tool/Template | Description | Price |
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 |
CTD 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 |
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Module 1 – USA |
IND Annual Report US M1 [14
files] |
$500 |
NDA Annual Report US M1 [12
files] |
$500 |
|
Module 1 – Canada |
Product Monograph |
$250 |
Certified Product Information Document [CPID] |
$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] |
Summary of Product Characteristics [SPC] |
$250 |
|
Module 2 – Clinical |
Clinical Overview and Clinical Summary [7 files] |
$700 |
Module 2 – Non Clinical |
Non Clinical Overview and Non Clinical Written Summary
[8 files] |
$1000 |
Module 2 - Quality |
Overall Summary
[20 files]
|
$300 |
Quality Overall Summary [Canada] |
$250 |
|
Module 3 - References |
Section 33 References
[included
with purchase of Module 3 templates] |
0 |
Module 3 – Drug Substance |
Section 3.2.S
[22 files] |
$1500 |
Module 3 – Drug Product |
Section 3.2.P
[24 files] |
$1500 |
Module 3 - Appendices |
Sections 3A and 3R [ 6 files]
[included with purchase of Module 3 templates] |
0 |
Module 3 – Stability Report |
Stability Report |
$350 |
Module 4 - Non Clinical Research Report |
Non Clinical Research Report |
$350 |
Module 5 - Investigators Brochure |
Investigators Brochure |
$350 |
Module 5 - Protocol |
Clinical Protocol |
$350 |
Module 5 - Clinical Study Report |
Clinical Study Report [body] |
$350 |
Module 5 - Synopsis |
Clinical Study Report Synopsis [included with CSR] |
0 |
Module 5 – CSR Appendices |
Clinical Appendices [16 files] |
$500 |
Module 5 – Tabular Listing |
5.2 Tabular Listing of Clinical Studies |
NC |
MEDICAL DEVICE TEMPLATES |
||
510k Premarket
Notification
|
||
510k template package |
510(k) Shell, Guidance and Applicable Templates |
$2500 |
EU Technical File, Essential Requirements Checklist, Declaration of Conformity |
||
EU Technical File, Design Dossier, Essential Requirements Checklist, Declaration of Conformity |
EU Technical File Shell, Guidance and Applicable Templates |
$2500 |
Design and Development
Planning |
||
Design & Development Plan
[Form100] |
Design & Development Plan |
$800 |
Form101 Technical Plan [Form101] |
Technical Plan |
$800 |
Quality Plan [Form102] |
Quality Plan |
$800 |
Regulatory Plan [Form103] |
Regulatory Plan |
$1200 |
Manufacturing Plan [Form104] |
Manufacturing Plan |
$800 |
Service & Support Plan [Form105] |
Service & Support Plan |
$800 |
Marketing Plan [Form106] |
Marketing Plan |
$800 |
Risk Management Plan [Form107] |
Risk Management Plan |
$1200 |
Design Input |
||
User Requirements Document [Form110] |
User Requirements Document |
$800 |
Design Input Requirements [Form111] |
Design Input Requirements |
$800 |
Design Output |
||
Manufacturing Readiness Report [Form120] |
Manufacturing Readiness Report |
$800 |
Commercialization Readiness Report [Form121] |
Commercialization Readiness Report |
$800 |
Design Reviews |
|
|
Design Review Meeting Minutes [Form130] |
Design Review Meeting Minutes |
$400 |
Design Verification |
|
|
Design Verification Plan [Form150] |
Design Verification Plan |
$1200 |
Design Verification Protocol [Form151] |
Design Verification Protocol |
$400 |
Design Verification Protocol Report [Form152] |
Design Verification Protocol Report |
$400 |
Design Verification Report [Form153] |
Design Verification Report |
$1200 |
Design Validation |
|
|
Design Validation Plan [Form160] |
Design Validation Plan |
$1200 |
Design Validation Protocol [Form161] |
Design Validation Protocol |
$400 |
Design Validation Protocol Report
[Form162] |
Design Validation Protocol Report
|
$400 |
Design Validation Report [Form163] |
Design Validation Report |
$1200 |
Risk Analysis Report [Form165] |
Risk Analysis Report |
$1200 |
Process Validation Plan [Form166] |
Process Validation Plan |
$800 |
Process Validation Report [Form167] |
Process Validation Report |
$800 |
Nonconforming Material Report [Form019] |
Nonconforming Material Report |
$800 |
Corrective/Preventative Action Deviation
Report [Form186] |
Corrective/Preventative Action Deviation
Report |
$800 |
Deviation Report [Form252] |
Deviation Report |
$800 |
Design History File |
|
|
Design History File Index [Form170] |
Design History File Index |
$400 |
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 |