PharmaReady eCTD Submissions Templates - Order Now

All prices in US dollars. If you have any questions about our purchasing policies click here.

ID	Description	$	Quantity
Authoring Toolbar
	Authoring Toolbar	2,200	add
CTD Submission Templates	Templates for creating eCTD compliant documents and submissions
Module 2 Clinical	7 Templates for Clinical Overview and Clinical Summary	700	add
Module 2 Quality	21 Templates for Quality Overall Summary	300	add
Module 2 Non Clinical	8 Templates for Non Clinical Overview, Non Clinical Written Summaries, and Non Clinical Tabulated Summaries	1,000	add
Module 2 TOC/Intro	1 Template for CTD Introduction	0	add
Module 3 Drug Substance	Drug Substance 22 Templates for Sections 3.2.S	1,500	add
Module 3 Drug Product	Drug Product 24 Templates for Sections 3.2.P	1,500	add
Module 3 Appendices & Regional	7 Templates for Sections 3A and 3R and 3.3 (no charge with any Module 3)	0	add
Module 5	1 Template for Tabular Listing of all Clinical Studies	0	add
Report Templates	Templates for creating compliant Reports
Protocol	Template for creating compliant Protocol	350	add
Clinical Study Report	Template for creating compliant Clinical Study Report	350	add
Stability Report	Template for creating compliant Stability Report	350	add
Investigator Brochure	Template for creating compliant Investigator Brochure	350	add
Standard Operating Procedures (SOPs)	Standard Operating Procedures for Document Management
SOP Template	Template for general SOP format	350	add
Authoring and Managing Documents	Procedure to outline the process for the development, storage, and control of change for submission related documents	350	add
Review, Approval & Finalization of Documents	Procedure to outline the process for review and approval of reports and submissions	350	add
Submission and Document Archiving Procedure	Procedure to outline the process for archiving hard copy and electronic documents and submissions into the official company repository (electronic and hard copy)	350	add
Development and Management of Documents Prepared by CROs, Partners & Consultants	Procedure for the development and management of documents prepared by contract research organizations, partners, and consultants	350	add
Preparation and Change Control of Standard Operating Procedures	Procedure for the preparation and change control of Standard Operating Procedures	350	add
Guides & Training
Guide to Using Templates & Basic Format Requirements	Guide to creating eCTD compliant documents		Included with all purchases
Online Training	4 hour blocks of online templates/toolbar training Not included in the Total Package	800	add

TOTAL PACKAGE		$9,900	add

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Click here for a sample template.