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eCTD – The mandatory format

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

The IWA Consulting Team offers full eCTD support for all regions: EU, US, Canada, Switzerland and others.

The IWA Consulting Team has a long term and hands on 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.

If you have submitted EU dossiers as NeeS we can assist you in converting your NeeS to eCTD format.

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 conversion to eCTD.

For more information about eCTD submissions, please contact Regulatory Operations Team.