Antrix, Inc ANTRIX, Inc
Regulatory Affairs & Quality Assurance Consulting Services for
Medical Device and Medicinal Drugs
O 408 733 1199
F 408 730 5959
 info@antrix.com

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

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