{"id":1023,"date":"2019-01-10T11:02:53","date_gmt":"2019-01-10T10:02:53","guid":{"rendered":"https:\/\/www.op-pharma.it\/?page_id=1023"},"modified":"2020-04-28T10:04:20","modified_gmt":"2020-04-28T08:04:20","slug":"technical-documentation","status":"publish","type":"page","link":"https:\/\/www.op-pharma.it\/en\/technical-documentation\/","title":{"rendered":"Technical Documentation"},"content":{"rendered":"

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Due Diligence Project and Solution, from digitalization to Base-Line e-CTD<\/h2>\n

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Due Diligence and eCTD Base Line Creation;<\/p>\n

\u2022<\/p>\n

Digitization of paper technical dossiers;<\/p>\n

\u2022<\/p>\n

CTD \/ NeeS \/ eCTD drafting from analytical and \/ or productive documentation;<\/p>\n

\u2022<\/p>\n

Updating and management of electronic documentation from NTA to CTD\/NeeS\/eCTD;<\/p>\n

\u2022<\/p>\n

Preparation, integration and sending of sections for New Applications, Responses, Variations and Renewals;<\/p>\n

\u2022<\/p>\n

eCTD Modules Submission EU\/CESP \u2013 GCC\/SFDA\/SDR \u2013 FDA\/ESG.<\/strong><\/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=”grid” angled_section=”no” text_align=”left” background_image_as_pattern=”without_pattern” css=”.vc_custom_1537866411940{padding-top: 40px !important;padding-bottom: 40px !important;background-color: #77c7f2 !important;}” z_index=”” el_class=”call-azzurra”][vc_column][vc_column_text]<\/p>\n

OP Pharma integrates the services listed above with e-Dox<\/a> <\/i><\/a><\/span><\/span><\/p>\n

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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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