{"id":1005,"date":"2019-01-10T10:56:14","date_gmt":"2019-01-10T09:56:14","guid":{"rendered":"https:\/\/www.op-pharma.it\/?page_id=1005"},"modified":"2019-01-14T12:15:02","modified_gmt":"2019-01-14T11:15:02","slug":"e-dox","status":"publish","type":"page","link":"https:\/\/www.op-pharma.it\/en\/e-dox\/","title":{"rendered":"e-Dox"},"content":{"rendered":"

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eCTD Management, Submission and safe Sharing of eCTD sequences<\/h2>\n

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

[\/vc_column_text][vc_separator type=”transparent” up=”30″][vc_column_text]e-Dox<\/strong> allows to generate the documentation ready to be submitted to any regulatory agency that accepts the eCTD format<\/strong>.<\/p>\n

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<\/strong> and final dossier.<\/p>\n

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

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<\/strong>) a regulated access programmed and defined by the Customer (even only to certain sections of the eCTD) for consultation purposes.<\/p>\n

No installation is required, just an Internet connection<\/strong>.[\/vc_column_text][\/vc_column][\/vc_row][vc_row css_animation=”” row_type=”row” use_row_as_full_screen_section=”no” type=”grid” angled_section=”no” text_align=”left” background_image_as_pattern=”without_pattern” css=”.vc_custom_1536844554963{padding-top: 40px !important;padding-bottom: 40px !important;background-color: #77c7f2 !important;}” z_index=””][vc_column][vc_column_text]<\/p>\n

SAFETY<\/b><\/span><\/h3>\n

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Antivirus, firewall and weekly data backup protect the OP Pharma information system.<\/span>
\nThe firewall filters the accesses to the system: the portal accepts only the IPs of accredited users regulated by the customers.<\/span><\/p>\n

[\/vc_column_text][\/vc_column][\/vc_row][vc_row css_animation=”” row_type=”row” use_row_as_full_screen_section=”no” type=”grid” angled_section=”no” text_align=”center” background_image_as_pattern=”without_pattern” css=”.vc_custom_1538130576258{padding-top: 40px !important;padding-bottom: 40px !important;background-color: #9bd4f3 !important;}” z_index=”” el_class=”call-azzurra”][vc_column]Request information on this service<\/a>[\/vc_column][\/vc_row][vc_row css_animation=”” row_type=”row” use_row_as_full_screen_section=”no” type=”full_width” angled_section=”no” text_align=”left” background_image_as_pattern=”without_pattern” css=”.vc_custom_1538130258505{padding-top: 25px !important;}” z_index=””][vc_column][vc_column_text]\"\"[\/vc_column_text][vc_column_text]<\/p>\n

All the services<\/strong><\/h2>\n

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Regulatory Practices<\/a><\/h3>\n

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e-Reg<\/a><\/h3>\n

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Technical Documentation<\/a><\/h3>\n

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e-Dox<\/a><\/h3>\n

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Consulting<\/a><\/h3>\n

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Outsourcing<\/a><\/h3>\n

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Contact us to request information on this Service<\/h3>\n

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