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Regulatory Compliant Document Management &
eSubmissions Product Suite

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PharmaReady - Recent News - eCTD and eDMS solution

TAKE Solutions’ Life Sciences Division Announces Global Expansion of its Submissions Assurance™ Program (more)

TAKE Solutions’ Team Announces Conatus Pharmaceuticals the Winner in PharmaReady Best Case Study Contest (more)

New eCTD Submission Created Using PharmaReady 4.0 Passes FDA Validation (more)

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 Total    
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.