| All prices in US dollars.
If you have any questions about our purchasing policies click
here |
| Product |
Description
|
| Authoring Tool [MS Word Add-in] |
| FrontEnd™ DocTemplate© |
Complements eCTDirect™ Templates and facilitates the creation of multipurpose documents for CTD and eCTD submissions.
Bundled free with purchase of full set of templates.
Price without templates on request.
|
[on request] |
| CTD Submission Templates |
| Module 2 -Clinical |
Templates for Clinical Overview and Clinical Summary (8) |
$700.00 |
Buy |
| Module 2 -Quality |
Templates for Quality Overall Summary (23) |
$300.00 |
Buy |
| Module 2 -Non-clinical |
Templates for Non Clinical Overview and Non Clinical Written Summaries (8) |
$1,000.00 |
Buy |
| Module 3 -Drug Substance |
Templates for Sections 3.2.S (24) |
$1,500.00 |
Buy |
| Module 3 -Drug Product |
Templates for Sections 3.2.P (24) |
$1,500.00 |
Buy |
| Module 3 -Appendices & Regional |
Templates for Sections 3A and 3R (7) - N/C with any Module 3 |
$0.00 |
Buy |
| Report Templates |
| Investigator Brochure |
Template for creating compliant Investigator Brochure |
$350.00 |
Buy |
| Protocol Report |
Template for creating compliant Protocol |
$350.00 |
Buy |
| Clinical Study Report |
Template for creating compliant Clinical Study Report |
$350.00 |
Buy |
| Stability Report |
Template for creating compliant Stability Report |
$350.00 |
Buy |
| Standard Operating Procedures (SOPs) |
| SOP Template |
Template for general SOP format |
$350.00 |
Buy |
| Authoring and Managing Documents |
Procedure to outline the process for the development, storage, and control of change for submission related documents. |
$350.00 |
Buy |
| Review, Approval & Finalization of Documents |
Procedure to outline the process for review and approval of reports and submissions |
$350.00 |
Buy |
| 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). |
$350.00 |
Buy |
| 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. |
$350.00 |
Buy |
| Preparation and Change Control of Standard Operating Procedures |
Procedure for the preparation and change control of Standard Operating Procedures |
$350.00 |
Buy |
| Guides |
| Guide to using Templates & Basic Format Requirements |
Guide to creating eCTD compliant documents |
Included with all purchases |
