OP Pharma

Regulatory Affairs Outsourcing and Consulting

Young and dynamic society

Dr. Osvaldo Ponchiroli

Performance, Services, Digital Regulatory

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e-Dox

eCTD Management, Submission and safe Sharing of eCTD sequences

e-Dox is a web-based system for the management of e-CTD dossier sequences (previous / subsequent to the base-line) according to the current ICH guidelines

e-Dox allows to generate the documentation ready to be submitted to any regulatory agency that accepts the eCTD format.

The approved documentation is always available for consultation and download: single section in Word and pdf format for the preparation of a new variation, eCTD and final dossier.

The updated sections in a sequence are visibly traced in the interface and once approved they become unmodifiable by any user (structure / content).

From the portal it is possible to dispose the sharing of the sections of the dossier with third parties (Production Site of the API / Finished Product, regulatory agencies, other MAH) a regulated access programmed and defined by the Customer (even only to certain sections of the eCTD) for consultation purposes.

No installation is required, just an Internet connection.

SAFETY

Antivirus, firewall and weekly data backup protect the OP Pharma information system.
The firewall filters the accesses to the system: the portal accepts only the IPs of accredited users regulated by the customers.

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