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eCTD/VNeeS Document and Submission Management

Document Management

Are you ready for the mandatory eCTD format? – We are!

The IWA Consulting Team has more than 15 years of experience in eCTD compiling, so whether you are facing initial eCTD submission or life cycle management we have solid expertise to advise and assist you all the way through the eCTD processes ensuring compliant eCTD dossier and meeting submission deadlines.

The IWA Consulting Team offers full eCTD support for EU, US, Canada, Switzerland and are specialised in eCTD submission across regions with a proven track record on global eCTD submissions taking place five months after Last Patient Last Visit. Global eCTD dossier (Module 2-5) with region specific Module 1 minimise preparation and/or review of documentation and reduce cost due to re-use of Module 2-5.

For regulatory dossiers, document format truly matters. Doing things right from the beginning will inevitably save you valuable time and resources. We know what it takes preparing templates and documents that are eCTD compatible.

For regulatory dossiers document format truly matters. Doing things right from the beginning is definitively the shortest and most cost efficient way to submission.

At IWA Consulting we have long term and hands on experience in handling eCTD and we know what it takes preparing documents and templates that are eCTD compatible.

The technical validation of an eCTD requires that the documents are converted to navigational PDF documents with the required settings for table of contents, bookmarks, hyperlinks etc. The IWA Consulting Team can help you converting Word documents to PDF using our Adlib PDF rendering software and optimising old PDF documents ensuring that all PDF requirements are met.

We have expertise in establishing efficient workflows and review cycles and in establishing the routines for finalisation and sign-off of quality controlled documents.

We offer to handle your eCTD in a fully integrated, validated and protected environment meeting CFR Part 11 specification.

The IWA Consulting Team can submit the eCTD through CESP, EMA eSubmission Gateway, FDA (ESG) and Health Canada (CESG) Electronic Submission Gateways.

Our team of experienced specialists also offers on-site or off-site assistance or training for a successful eCTD submission.

Finally, we also offer full support for your VNeeS submission both compiling and submitting through applicable portals or gateways.

For more information about eCTD/VNeeS document and submission management, please contact Sanne Elitha Svendsen, Head Regulatory Development or Lisbeth Lyme, Head Market Access & Life Cycle Management.