Chestnut Solutions Inc Chestnut Solutions Inc
 

Documents / Price List

Inventory of Templates and Price List

 

All prices in US dollars. 

Authoring Tool + Document Inventory

DocTemplateÓ Authoring Tool

for Word 93-2003

 

DocTemplateÓ 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

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 [7 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

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

Investigational Device Exemption (IDE)

 

 

 

(PMA)

 

 

 

Design and Development Planning

Design & Development Plan [Form 100]

Design & Development Plan

800

Form 101 Technical Plan [Form 101]

Technical Plan

800

Quality Plan [Form 102]

Quality Plan

800

Regulatory Plan [Form 103]

Regulatory Plan

1200

Manufacturing Plan [Form 104]

Manufacturing Plan

800

Service & Support Plan [Form 105]

Service & Support Plan

800

Marketing Plan [Form 106]

Marketing Plan

800

Risk Management Plan [Form 107]

Risk Management Plan

1200

Design Input

User Requirements Document

[Form 110]

User Requirements Document

800

Design Input Requirements

[Form 111]

Design Input Requirements

800

Design Output

Manufacturing Readiness Report

[Form 120]

Manufacturing Readiness Report

800

Commercialization Readiness Report

[Form 121]

Commercialization Readiness Report

800

Design Reviews

 

Design Review Meeting Minutes

Design Review Meeting Minutes

400

Design Verification

 

Design Verification Plan [Form 150]

Design Verification Plan

1200

Design Verification Protocol

[Form 151]

Design Verification Protocol

400

Design Verification Protocol Report [Form 152]

Design Verification Protocol Report

400

Design Verification Report [Form 153]

Design Verification Report

1200

Design Validation

 

Design Validation Plan [Form 160]

Design Validation Plan

1200

Design Validation Protocol [Form 161]

Design Validation Protocol

400

Design Validation Protocol Report [Form 162]

Design Validation Protocol Report

400

Design Validation Report [Form 163]

Design Validation Report

1200

Risk Analysis Report [Form 165]

Risk Analysis Report

1200

Process Validation Plan [Form 166]

Process Validation Plan

800

Process Validation Report [Form 167]

Process Validation Report

800

Nonconforming Material Report [Form 019]

Nonconforming Material Report

800

Corrective/Preventative Action Deviation Report [Form 186]         

Corrective/Preventative Action Deviation Report           

800

Deviation Report [Form 252]

Deviation Report

800

Design History File

 

Design History File Index [Form 170]

Design History File Index

400