Our eCTD / CTD templates are simple, effective and come ready to use. The templates use Microsoft Word styles for consistency of formatting, and... Read more...


iRegulatory's eCTD resource pages - your first port of call for information on eCTD and electronic submissions. This website has the latest news you... Read more...


We have an innovative tool that produces an eCTD readiness report, based on responses given in an online questionnaire which is completed on an... Read more...
Join our mailing list



 

 

The following list is of our previous FREE newsletters. They're packed with articles from both us and other contributors, top tips, and our 'Tea Break' feature. If you haven't subscribed and would like to, please use the form on the left.

Call for articles! Would you like to demonstrate your expertise in a particular subject? Know a lot about a hot topic that you'd like to share with our readers? If so, we'd love to hear from you! All suggestions welcome.

   
Archive
May 2010 Agency eSubmission Validation Experience‏
Apr 2010 How are companies compiling NeeS submissions?
Mar 2010 eSubmission news and PIM latest

Feb 2010

Review of the updated CMD(h) best practice for eCTD in MRP and DCP 
   
Previous Articles
 

Jan 2010

PIM to make our lives easier

Dec 2009

Regulation of Advanced Therapies

Nov 2009

Electronic submissions: recent developments

Oct 2009

PIM for Electronic Submission of Product Information

 

PIM for Electronic Submission of Product Information - Part Two 

Aug 2009

Version 1.4 of the EU Module 1 specification

Jul 2009

eCTD Publishing: The case for Outsourcing

May 2009

TIGes guidance for Industry on eCTD submissions 

Apr 2009

Counterfeit Medicines 

Feb 2009

Good Regulatory Practices 

Jan 2009

eCTD ready documents 

Nov 2008

Nonclinical Overviews for Generics

Sep 2008

Outsourcing Medical Writing

May 2008

eCTD: Back to basics

 
Copyright © 2010 iRegulatory Ltd. All Rights Reserved.