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ServiceUpdated on 9 April 2025

e-Dox: management of eCTDs

Federico Ponchiroli

Product manager at O.P. Pharma Srl

Milan, Italy

About

OP Pharma has been providing innovative services in the Regulatory Affairs field for more than 20 years to small to big pharma Companies in Italy as well as in the European Union.

Do you have dossiers of which you would like to outsource the management and update to their latest eCTD (EU, FDA, SFDA, etc...) versions in one place and communicate relevant updates to third parties?

By means of our self-developed IT program e-Dox, we offer customized IT solutions for the management of the eCTDs of all of your products and relevant sequences, including submissions, incorporation of new versions as well as consolidating, tracking, displaying and exporting the uploaded documents from hundreds of products and thousands of packs.

With the user-friendly interface of e-Dox, you'll have fully-secure, direct online access from the browser to your own eCTDs and will easily and quickly find the needed information/document (.pdf or word files) or download one or all sequences or the consolidated version of your eCTD.

Not only that: you may allow access to third parties (manufacturers, consultants, Authorities, etc...) for consulting your dossier and customize the sending of notifications upon occurrence of defined updates.

You don't need to install any softwares, there is no user-count limitation or deadline for documentation availability; the customized e-mail alert service is included too.

Do not hesitate to contact us for more information or for a quotation.

See more:

https://www.op-pharma.it/e-dox/

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