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Publishing & eCTD
Services:
Tackling Global
Submission
[/fusion_title][fusion_separator style_type=”none” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” sep_color=”rgba(255,252,252,0)” top_margin=”40px” bottom_margin=”” border_size=”” icon=”” icon_circle=”” icon_circle_color=”” width=”” alignment=”center” /][/fusion_builder_column][fusion_builder_column type=”1_2″ layout=”1_2″ last=”true” spacing=”yes” center_content=”no” hide_on_mobile=”no” background_color=”” background_image=”” background_repeat=”no-repeat” background_position=”left top” hover_type=”none” link=”” border_position=”all” border_color=”” border_style=”” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” margin_top=”” margin_bottom=”” animation_type=”” animation_direction=”” animation_speed=”0.1″ animation_offset=”” class=”” id=”” min_height=”” first=”false” border_sizes_top=”0px” border_sizes_bottom=”0px” border_sizes_left=”0px” border_sizes_right=”0px” spacing_left=”2%”][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]Life sciences companies face a host of operational challenges with managing global regulatory affairs submissions. These include meeting complex timelines, fluctuation in submission volume throughout the year, variations in requirements from region to region, and the complexity of gathering data from different functions and from affiliates. In addition, companies must deal with the logistical challenges of managing IT tools and systems, many of which don’t provide an end-to-end view of the submission process.[/fusion_text][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” content_alignment_medium=”” content_alignment_small=”” content_alignment=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” font_size=”20px” fusion_font_family_text_font=”Poppins” fusion_font_variant_text_font=”500″ line_height=”30px” letter_spacing=”” text_color=”#6ecbd5″ animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]
Celegence: a Global Perspective to Submission Publishing
[/fusion_text][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]Celegence provides dossier submission services worldwide, supporting both eCTD and Non-eCTD electronic submissions [NeeS] formats. All submission services are supported by our experienced regulatory intelligence team, whose deep knowledge of local and regional guidelines ensure the provision of compliant and efficient regulatory publishing services. We can help streamline your end-to-end submissions management process, from dossier development to health authority interactions.[/fusion_text][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]Our eCTD publishing services and document level publishing expertise take the complexity out of commonly experienced problems, such as formatting and hyperlinking issues, floating sections, and error corrections.[/fusion_text][/fusion_builder_column][/fusion_builder_row][/fusion_builder_container][fusion_builder_container admin_label=”” type=”legacy” hundred_percent=”no” hundred_percent_height=”no” min_height_medium=”” min_height_small=”” min_height=”” hundred_percent_height_scroll=”no” align_content=”stretch” flex_align_items=”flex-start” 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letter_spacing=”” text_shadow=”no” text_shadow_vertical=”” text_shadow_horizontal=”” text_shadow_blur=”0″ text_shadow_color=”” margin_top_medium=”” margin_right_medium=”” margin_bottom_medium=”” margin_left_medium=”” margin_top_small=”” margin_right_small=”” margin_bottom_small=”” margin_left_small=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” gradient_font=”no” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ highlight_color=”” style_type=”default” sep_color=”” link_color=”” link_hover_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]
Celegence’s Dedicated Offerings Support
[/fusion_title][fusion_separator style_type=”none” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” flex_grow=”0″ top_margin=”10px” bottom_margin=”” width=”” alignment=”center” border_size=”2″ sep_color=”rgba(6,72,105,0)” icon=”” icon_size=”” icon_color=”” icon_circle=”” icon_circle_color=”” /][fusion_checklist icon=”fa-check fas” iconcolor=”#6ecbd5″ circle=”” circlecolor=”rgba(45,169,224,0)” size=”16px” divider=”” divider_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=””][fusion_li_item icon=””]Dossier submission services to multiple health authorities[/fusion_li_item][/fusion_checklist][fusion_separator style_type=”single solid” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” flex_grow=”0″ top_margin=”15px” bottom_margin=”15px” width=”” alignment=”center” border_size=”2″ sep_color=”#6ecbd5″ icon=”” icon_size=”” icon_color=”” icon_circle=”” icon_circle_color=”” /][fusion_checklist icon=”fa-check fas” iconcolor=”#6ecbd5″ circle=”” circlecolor=”rgba(45,169,224,0)” size=”16px” divider=”” divider_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=””][fusion_li_item icon=””]Paper to NeeS to eCTD conversions in keeping with health authority formats worldwide[/fusion_li_item][/fusion_checklist][fusion_separator style_type=”single solid” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” flex_grow=”0″ top_margin=”15px” bottom_margin=”15px” width=”” alignment=”center” border_size=”2″ sep_color=”#6ecbd5″ icon=”” icon_size=”” icon_color=”” icon_circle=”” icon_circle_color=”” /][fusion_checklist icon=”fa-check fas” iconcolor=”#6ecbd5″ circle=”” circlecolor=”rgba(45,169,224,0)” size=”16px” divider=”” divider_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=””][fusion_li_item icon=””]Regulatory intelligence services to interpret regional and national requirements for submissions[/fusion_li_item][/fusion_checklist][fusion_separator style_type=”single solid” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” flex_grow=”0″ top_margin=”15px” bottom_margin=”15px” width=”” alignment=”center” border_size=”2″ sep_color=”#6ecbd5″ icon=”” icon_size=”” icon_color=”” icon_circle=”” icon_circle_color=”” /][fusion_checklist icon=”fa-check fas” iconcolor=”#6ecbd5″ circle=”” circlecolor=”rgba(45,169,224,0)” size=”18px” divider=”” divider_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=””][fusion_li_item icon=””]Comprehensive quality check and adherence to predefined SLAs[/fusion_li_item][/fusion_checklist][fusion_separator style_type=”single solid” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” flex_grow=”0″ top_margin=”15px” bottom_margin=”15px” width=”” alignment=”center” border_size=”2″ sep_color=”#6ecbd5″ icon=”” icon_size=”” icon_color=”” icon_circle=”” icon_circle_color=”” /][fusion_checklist icon=”fa-check fas” iconcolor=”#6ecbd5″ circle=”” circlecolor=”rgba(45,169,224,0)” size=”16px” divider=”” divider_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=””][fusion_li_item icon=””]
Extension of the in-house publishing team and management of the submission tools with Business Process as a Service (BPaaS) model
[/fusion_li_item][/fusion_checklist][fusion_separator style_type=”single solid” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” flex_grow=”0″ top_margin=”15px” bottom_margin=”15px” width=”” alignment=”center” border_size=”2″ sep_color=”#6ecbd5″ icon=”” icon_size=”” icon_color=”” icon_circle=”” icon_circle_color=”” /][fusion_checklist icon=”fa-check fas” iconcolor=”#6ecbd5″ circle=”” circlecolor=”rgba(45,169,224,0)” size=”16px” divider=”” divider_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=””][fusion_li_item icon=””]
End to end services for Publishing, Submission and Archival of Dossiers for multiple regions
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Management and Submission of IND Safety & Adverse Event Reports
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