Regulatory Publishing & Submission Management

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Timely and Accurate Delivery First-Time

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Looking for a Global Dossier Publishing & Submissions Partner?

[/fusion_title][fusion_youtube id=”https://www.youtube.com/watch?v=SeiVzPS0qRg” alignment=”center” width=”641px” height=”360.5px” autoplay=”true” mute=”true” api_params=”&rel=0″ title_attribute=”Regulatory Publishing & Submission Management” video_facade=”on” thumbnail_size=”auto” margin_top=”” margin_bottom=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” css_id=”” structured_data=”off” video_upload_date=”” video_duration=”” video_title=”” video_desc=”” /][/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_title title_type=”text” marquee_direction=”left” marquee_speed=”15000″ rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” title_link=”off” link_url=”” link_target=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” content_align_medium=”” content_align_small=”” content_align=”left” size=”3″ animated_font_size=”” fusion_font_family_title_font=”Poppins” fusion_font_variant_title_font=”500″ font_size=”25px” line_height=”” letter_spacing=”” text_transform=”” text_color=”” hue=”” saturation=”” lightness=”” alpha=”” animated_text_color=”” text_shadow=”no” text_shadow_vertical=”” text_shadow_horizontal=”” text_shadow_blur=”0″ text_shadow_color=”” text_stroke=”no” text_stroke_size=”1″ text_stroke_color=”” text_overflow=”none” 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=”” 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_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=””]Tackling Global Submission[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”” rule_size=”” rule_color=”” hue=”” saturation=”” lightness=”” alpha=”” 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=”” fusion_font_family_text_font=”” fusion_font_variant_text_font=”” font_size=”” line_height=”” letter_spacing=”” text_transform=”” text_color=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=”” logics=””]

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.

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Your goal: Efficient Global Publishing & Submissions

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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.

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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.

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Who We Have Helped with Publishing:

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The Team and Software To Make Publishing Easier

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Our publishing experts collaborate with you as an extension of your team via our proprietary solution, Dossplorer™

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See how Celegence AI-Enabled Experts can 4x your teams efficiency and save you 10% on costs compared to your current solutions!

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Manage eCTD and NeeS Worldwide

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Global Submissions

Dossier submission services to multiple health authorities.

Seamless Format Conversions

Paper to NeeS to eCTD conversions in keeping with health authority formats worldwide.

Expert Regulatory Insights

Regulatory intelligence services to interpret regional and national requirements for submissions.

Quality Assurance

Comprehensive quality check and adherence to predefined SLAs.

Integrated BPaaS Support

Extension of the in-house publishing team and management of the submission tools with Business Process as a Service (BPaaS) model.

Complete Dossier Services

End to end services for Publishing, Submission and Archival of Dossiers for multiple regions.

IND Safety Management

Management and Submission of IND Safety & Adverse Event Reports.

Document Formatting

Document Formatting and Publishing – Word Style Guides and PDF Navigation.

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Dossplorer™ At A Glance

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PowerSearch™ – Intuitive Full Text Search Functionality

Find documents and filter searches in seconds, using PowerSearch. The advanced search module scans the full content, and the metadata enables users to find documents and registrations instantly.

20+ Unique Views of your Dossiers

Holistic view across products and applications worldwide (including across-Dossiers view) allows for easy comparison of content and data across multiple eCTDs.

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margin_bottom=”” margin_left=”” fusion_font_family_text_font=”Poppins” fusion_font_variant_text_font=”500″ font_size=”20px” line_height=”” letter_spacing=”” text_transform=”” text_color=”#152549″ animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=”” logics=””]Import any File & Folder Structure[/fusion_text][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”” rule_size=”” rule_color=”” hue=”” saturation=”” lightness=”” alpha=”” 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=”” fusion_font_family_text_font=”” fusion_font_variant_text_font=”” font_size=”” line_height=”” letter_spacing=”” text_transform=”” text_color=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=”” logics=””]Besides eCTDs and NeeS, import any regulatory application, such as volumised PDFs, CTAs, IMPDs, PIP and Medical Devices.[/fusion_text][/fusion_builder_column][fusion_builder_column type=”1_4″ layout=”1_4″ align_self=”auto” content_layout=”column” align_content=”flex-start” valign_content=”flex-start” content_wrap=”wrap” spacing=”3%” center_content=”no” column_tag=”div” link=”” target=”_self” link_description=”” min_height=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” type_medium=”” type_small=”” flex_grow_medium=”” flex_grow_small=”” flex_grow=”” flex_shrink_medium=”” flex_shrink_small=”” flex_shrink=”” order_medium=”0″ order_small=”0″ spacing_left_medium=”” spacing_right_medium=”” spacing_left_small=”” spacing_right_small=”” spacing_left=”” spacing_right=”0%” margin_top_medium=”” margin_bottom_medium=”” margin_top_small=”” 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transform_skew_x_hover=”0″ transform_skew_y_hover=”0″ transform_scale_x=”1″ transform_scale_y=”1″ transform_translate_x=”0″ transform_translate_y=”0″ transform_rotate=”0″ transform_skew_x=”0″ transform_skew_y=”0″ transform_origin=”” transition_duration=”300″ transition_easing=”ease” transition_custom_easing=”” motion_effects=”W10=” scroll_motion_devices=”small-visibility,medium-visibility,large-visibility” animation_type=”” animation_direction=”right” animation_color=”” animation_speed=”1.0″ animation_delay=”0″ animation_offset=”” last=”false” border_position=”all” first=”false”][fusion_fontawesome icon=”fa-robot fas” size=”” flip=”” rotate=”” spin=”no” link=”” linktarget=”_self” alignment_medium=”” alignment_small=”” alignment=”center” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” iconcolor_hover=”” hue=”” saturation=”” lightness=”” alpha=”” iconcolor=”var(–awb-custom13)” circle=”no” bg_size=”-1″ circlecolor_hover=”” circlecolor=”” circlebordersize=”” circlebordercolor_hover=”” circlebordercolor=”” border_radius_top_left=”” border_radius_top_right=”” border_radius_bottom_right=”” border_radius_bottom_left=”” icon_hover_type=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=”” /][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=”15px” bottom_margin=”” width=”” alignment=”center” border_size=”” sep_color=”rgba(255,252,252,0)” icon=”” icon_size=”” icon_color=”” icon_circle=”” icon_circle_color=”” /][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”” rule_size=”” rule_color=”” hue=”” saturation=”” lightness=”” alpha=”” content_alignment_medium=”” content_alignment_small=”” content_alignment=”left” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” fusion_font_family_text_font=”Poppins” fusion_font_variant_text_font=”500″ font_size=”20px” line_height=”” letter_spacing=”” text_transform=”” text_color=”#152549″ animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=”” logics=””]Dossplorer Xchange Bot & Automated Import Agent[/fusion_text][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”” rule_size=”” rule_color=”” hue=”” saturation=”” lightness=”” alpha=”” 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=”” fusion_font_family_text_font=”” fusion_font_variant_text_font=”” font_size=”” line_height=”” letter_spacing=”” text_transform=”” text_color=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=”” logics=””]Avoid manual steps with the automatic transfer and import of applications and submissions to the Dossplorer private cloud.[/fusion_text][/fusion_builder_column][fusion_builder_column type=”1_4″ layout=”1_4″ align_self=”auto” content_layout=”column” align_content=”flex-start” valign_content=”flex-start” content_wrap=”wrap” spacing=”3%” center_content=”no” column_tag=”div” link=”” target=”_self” link_description=”” min_height=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” type_medium=”” type_small=”” flex_grow_medium=”” flex_grow_small=”” flex_grow=”” flex_shrink_medium=”” flex_shrink_small=”” flex_shrink=”” order_medium=”0″ order_small=”0″ spacing_left_medium=”” 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transform_hover_element=”self” transform_scale_x_hover=”1″ transform_scale_y_hover=”1″ transform_translate_x_hover=”0″ transform_translate_y_hover=”0″ transform_rotate_hover=”0″ transform_skew_x_hover=”0″ transform_skew_y_hover=”0″ transform_scale_x=”1″ transform_scale_y=”1″ transform_translate_x=”0″ transform_translate_y=”0″ transform_rotate=”0″ transform_skew_x=”0″ transform_skew_y=”0″ transform_origin=”” transition_duration=”300″ transition_easing=”ease” transition_custom_easing=”” motion_effects=”W10=” scroll_motion_devices=”small-visibility,medium-visibility,large-visibility” animation_type=”” animation_direction=”right” animation_color=”” animation_speed=”1.0″ animation_delay=”0″ animation_offset=”” last=”true” border_position=”all” first=”false”][fusion_fontawesome icon=”fa-compress-alt fas” size=”” flip=”” rotate=”” spin=”no” link=”” linktarget=”_self” alignment_medium=”” alignment_small=”” alignment=”center” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” iconcolor_hover=”” hue=”” saturation=”” lightness=”” alpha=”” iconcolor=”var(–awb-custom13)” circle=”no” bg_size=”-1″ circlecolor_hover=”” circlecolor=”” circlebordersize=”” circlebordercolor_hover=”” circlebordercolor=”” border_radius_top_left=”” border_radius_top_right=”” border_radius_bottom_right=”” border_radius_bottom_left=”” icon_hover_type=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=”” /][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=”15px” bottom_margin=”” width=”” alignment=”center” border_size=”” sep_color=”rgba(255,252,252,0)” icon=”” icon_size=”” icon_color=”” icon_circle=”” icon_circle_color=”” /][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”” rule_size=”” rule_color=”” hue=”” saturation=”” lightness=”” alpha=”” content_alignment_medium=”” content_alignment_small=”” content_alignment=”left” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” fusion_font_family_text_font=”Poppins” fusion_font_variant_text_font=”500″ font_size=”20px” line_height=”” letter_spacing=”” text_transform=”” text_color=”#152549″ animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=”” logics=””]Compare Documents & Compare Document Versions functionality.[/fusion_text][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”” rule_size=”” rule_color=”” hue=”” saturation=”” lightness=”” alpha=”” 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=”” fusion_font_family_text_font=”” fusion_font_variant_text_font=”” font_size=”” line_height=”” letter_spacing=”” text_transform=”” text_color=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=”” logics=””]Utilize automated comparison features to seamlessly identify changes in content between documents versions. Compare the content of any 2 documents (e.g. to see how certain documents differ across registrations/different markets).[/fusion_text][/fusion_builder_column][fusion_builder_column type=”1_1″ layout=”1_1″ align_self=”auto” content_layout=”column” align_content=”flex-start” valign_content=”flex-start” content_wrap=”wrap” spacing=”” center_content=”no” column_tag=”div” link=”” target=”_self” link_description=”” min_height=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” type_medium=”” type_small=”” flex_grow_medium=”” flex_grow_small=”” flex_grow=”” flex_shrink_medium=”” flex_shrink_small=”” flex_shrink=”” order_medium=”0″ order_small=”0″ dimension_spacing_medium=”” dimension_spacing_small=”” dimension_spacing=”” dimension_margin_medium=”” dimension_margin_small=”” margin_top=”” margin_bottom=”” padding_medium=”” padding_small=”” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” hover_type=”none” 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3 Ways We Make you More Successful

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Faster Turnaround Times

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Establish a global Publishing & Submission delivery team with 18 hour global coverage.