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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
Module 1 – USA	NDA Annual Report US M1 [12 files]	$500
Module 1 – Canada	Product Monograph	$250
Module 1 – Canada	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]
Module 1 - EU	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