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PharmaReady eCTD Submissions Templates - Order Now

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ID Description $ Quantity Total
Authoring Toolbar Facilitates the creation of documents for CTD and eCTD submissions
DocTemplate™ Authoring Toolbar 2,200   add
CTD Submission Templates Templates for creating eCTD compliant documents
and submissions
Module 1
IND Annual Report		 9 Templates for CMC, IND Amendments & Annual Reports 350   add
Module 2 Clinical 7 Templates for Clinical Overview and Clinical Summary 700   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 Quality 23 Templates for Quality Overall Summary 300   add
Module 2 TOC/Introduction 2 Templates for CTD Introduction (included with any Module 2) 0   add
Module 3 Drug Product 24 Templates for Sections 3.2.P 1,500   add
Module 3 Drug Substance 24 Templates for Sections 3.2.S 1,500   add
Module 3 Appendices & Regional 7 Templates for Sections 3A and 3R and 3.3 (included with any Module 3) 0   add
Module 5 1 Template for Tabular Listing of all Clinical Studies (included with any Module 2) 0   add
Report Templates Templates for creating compliant Reports
Clinical Study Report Template for creating compliant Clinical Study Report 350   add
Investigators Brochure Template for creating compliant Investigators Brochure 350   add
Protocol Report Template for creating compliant Protocol Report 350   add
Stability Report Template for creating compliant Stability Report 350   add
RA Product Monograph [Canada] Template for creating compliant RA Product Monograph 350   add
Standard Operating Procedures (SOPs) Standard Operating Procedures for Document Management
SOP Template Template for creating other SOPs 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
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
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
Laboratory Notebooks Procedure for managing laboratory notebooks 350   add
Preparation and Change Control of Standard Operating Procedures Procedure for the preparation and change control of Standard Operating Procedures 350   add
Review, Approval & Finalization of Documents Procedure to outline the process for review and approval of reports and submissions 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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