Technical Documentation

Due Diligence Project and Solution, from digitalization to Base-Line e-CTD

Due Diligence and eCTD Base Line Creation;
Digitization of paper technical dossiers;
CTD / NeeS / eCTD drafting from analytical and / or productive documentation;
Conversion from NtA to CTD/NeeS/eCTD;
Updating and management of electronic documentation (CTD/NeeS/eCTD);
Preparation, integration and sending of sections for New Applications, Responses, Variations and Renewals;
eCTD Modules Submission EU/CESP – GCC/SFDA/SDR – FDA/ESG.

e-Dox is a web-based system for the secure management of sequences (before/after the baseline) of eCTD dossiers in accordance with current ICH guidelines.

e-Dox

eCTD Management, Submission and Sharing for secure management and sharing of eCTD sequences.

Through e-Dox it is possible to perform submissions to any regulatory authority that accepts the eCTD format.

The approved documentation is always available for consultation and download: individual sections in Word format for preparing a new variation, eCTD, consolidated dossier.

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

From the portal it is possible to share dossier sections, granting third parties (active substance/product manufacturing sites, regulatory authorities, other MAHs) scheduled and client-defined access (including access limited to specific eCTD sections) for consultation purposes.

No installation is required, only an Internet connection.

System security

OP Pharma’s IT system is protected by antivirus, firewall, and weekly data backups.

Filters

The firewall filters system access: only the IPs of accredited clients can access the portal.

Backup

Data backups are performed weekly in duplicate, and a copy is provided directly to the client via FTP.