Have you ever considered submitting your registration file as a global eCTD with the EMA and FDA simultaneously?
The IWA Consulting Team specializes in global eCTD submissions.
We have a proven track record on global eCTD submissions taking place five months after Last Patient Last Visit.
Just how do we manage to do that? Knowing our line of work and executing with experience enables us to navigate past pitfalls and through shortcuts.
We ensure that all documents are eCTD compatible and can be used in the eCTD for the MAA as well as the NDA, and with a solid combination of experience, expertise, and courage to challenge given differences and apparent incompatibilities between registration files, the IWA Consulting Team can help you find the fastest and most cost-effective way through registration to market.
Global eCTD dossier (Module 2-5) with region specific Module 1 includes preparation and or/review of documentation and reduced cost due to re-use of Module 2-5.
The IWA Consulting Team can submit the eCTD through CESP, EMA eSubmission Gateway, FDA (ESG) and Health Canada (CESG) Electronic Submission Gateways.
Please contact us, to discuss the opportunities for a global eCTD submission.