{"id":2829,"date":"2023-10-20T14:14:55","date_gmt":"2023-10-20T12:14:55","guid":{"rendered":"https:\/\/proinnovera.com\/?page_id=2829"},"modified":"2024-01-19T09:15:26","modified_gmt":"2024-01-19T08:15:26","slug":"regulatory-affairs","status":"publish","type":"page","link":"https:\/\/proinnovera.com\/de\/services\/regulatory-affairs\/","title":{"rendered":"Regulatory Affairs"},"content":{"rendered":"[vc_row type=“full_width_content“ full_screen_row_position=“middle“ column_margin=“default“ column_direction=“default“ column_direction_tablet=“default“ column_direction_phone=“default“ scene_position=“center“ text_color=“dark“ text_align=“left“ row_border_radius=“none“ row_border_radius_applies=“bg“ overlay_strength=“0.3″ gradient_direction=“left_to_right“ shape_divider_position=“bottom“ bg_image_animation=“none“ shape_type=““][vc_column column_padding=“no-extra-padding“ column_padding_tablet=“inherit“ column_padding_phone=“inherit“ column_padding_position=“all“ column_element_spacing=“default“ background_color_opacity=“1″ background_hover_color_opacity=“1″ column_shadow=“none“ column_border_radius=“none“ column_link_target=“_self“ gradient_direction=“left_to_right“ overlay_strength=“0.3″ width=“1\/1″ tablet_width_inherit=“default“ tablet_text_alignment=“default“ phone_text_alignment=“default“ bg_image_animation=“none“ border_type=“simple“ column_border_width=“none“ column_border_style=“solid“]\t\t\t
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Regulatory Affairs<\/span><\/strong>
\nGenehmigung Ihrer Studie in k\u00fcrzester Zeit<\/span><\/p>\n\t\t\t\t\t<\/div>\n\t\t\t\t\n\t\t\t<\/section>\n\n\t\t[\/vc_column][\/vc_row][vc_row type=“full_width_background“ full_screen_row_position=“middle“ column_margin=“default“ column_direction=“default“ column_direction_tablet=“default“ column_direction_phone=“default“ scene_position=“center“ top_padding=“40″ bottom_padding=“40″ left_padding_desktop=“20″ right_padding_desktop=“20″ top_padding_phone=“20″ bottom_padding_phone=“20″ left_padding_phone=“20″ right_padding_phone=“20″ text_color=“dark“ text_align=“left“ row_border_radius=“none“ row_border_radius_applies=“bg“ overlay_strength=“0.3″ gradient_direction=“left_to_right“ shape_divider_position=“bottom“ bg_image_animation=“none“ shape_type=““][vc_column column_padding=“no-extra-padding“ column_padding_tablet=“inherit“ column_padding_phone=“inherit“ column_padding_position=“all“ left_margin=“auto“ right_margin=“auto“ left_margin_tablet=“auto“ right_margin_tablet=“auto“ left_margin_phone=“auto“ right_margin_phone=“auto“ column_element_spacing=“default“ centered_text=“true“ background_color_opacity=“1″ background_hover_color_opacity=“1″ column_shadow=“none“ column_border_radius=“none“ column_link_target=“_self“ gradient_direction=“left_to_right“ overlay_strength=“0.3″ width=“1\/1″ tablet_width_inherit=“default“ tablet_text_alignment=“default“ phone_text_alignment=“default“ bg_image_animation=“none“ border_type=“simple“ column_border_width=“none“ column_border_style=“solid“][vc_column_text css=“.vc_custom_1705652123316{margin-bottom: 40px !important;}“]\n

Die Einhaltung regulatorischer Vorschriften wird immer komplexer. Wir unterst\u00fctzen Sie dabei, fr\u00fchzeitig zu beginnen und sich gr\u00fcndlich auf die Dokumenteneinreichung vorzubereiten. Profitieren Sie von unserer (CTIS) Erfahrung und der gut etablierten Kommunikation mit den Pr\u00fcfstellen.<\/p>\n

Schnelle Genehmigung Ihrer klinischen Studie mithilfe unserer r<\/strong>egulatorischen Kompetenz von Symbio Proinnovera CRO.<\/strong><\/h1>\n[\/vc_column_text]\t\t\tJetzt kontaktieren\t\t\t\t\t\t\t\t\t<\/g><\/svg>\n\t\t\t\t\t\t\t\t<\/a>\n\n\t\t[\/vc_column][\/vc_row][vc_row type=“full_width_background“ full_screen_row_position=“middle“ column_margin=“default“ column_direction=“default“ column_direction_tablet=“default“ column_direction_phone=“default“ bg_color=“#d0e7e9″ scene_position=“center“ top_padding=“60″ bottom_padding=“60″ left_padding_desktop=“20″ right_padding_desktop=“20″ top_padding_tablet=“60″ bottom_padding_tablet=“60″ left_padding_tablet=“20″ right_padding_tablet=“20″ top_padding_phone=“40″ bottom_padding_phone=“40″ left_padding_phone=“20″ right_padding_phone=“20″ text_color=“dark“ text_align=“center“ row_border_radius=“none“ row_border_radius_applies=“bg“ overlay_strength=“0.3″ gradient_direction=“left_to_right“ shape_divider_position=“bottom“ bg_image_animation=“none“ shape_type=““][vc_column column_padding=“no-extra-padding“ column_padding_tablet=“inherit“ column_padding_phone=“inherit“ column_padding_position=“all“ column_element_spacing=“default“ background_color_opacity=“1″ background_hover_color_opacity=“1″ column_shadow=“none“ column_border_radius=“none“ column_link_target=“_self“ gradient_direction=“left_to_right“ overlay_strength=“0.3″ width=“1\/1″ tablet_width_inherit=“default“ tablet_text_alignment=“default“ phone_text_alignment=“default“ bg_image_animation=“none“ border_type=“simple“ column_border_width=“none“ column_border_style=“solid“][vc_column_text]\n
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EU\/EEA: Verwaltung einer klinischen Studie \u00fcber CTIS<\/span><\/h2>\n<\/div>\n<\/div>\n<\/div>\n

Die Einreichung \u00fcber CTIS ist bei uns seit dem 31. Januar 2023 obligatorisch.<\/strong><\/p>\n[\/vc_column_text][divider line_type=“No Line“][vc_row_inner equal_height=“yes“ content_placement=“top“ column_margin=“default“ column_direction=“default“ column_direction_tablet=“default“ column_direction_phone=“default“ text_align=“left“ class=“equal–height“][vc_column_inner column_padding=“no-extra-padding“ column_padding_tablet=“inherit“ column_padding_phone=“inherit“ column_padding_position=“all“ column_element_spacing=“default“ background_color_opacity=“1″ background_hover_color_opacity=“1″ column_shadow=“none“ column_border_radius=“none“ column_link_target=“_self“ gradient_direction=“left_to_right“ overlay_strength=“0.3″ width=“1\/1″ tablet_width_inherit=“default“ bg_image_animation=“none“ border_type=“simple“ column_border_width=“none“ column_border_style=“solid“][image_with_animation image_url=“2835″ animation=“Fade In“ hover_animation=“none“ alignment=““ border_radius=“none“ box_shadow=“none“ image_loading=“default“ max_width=“100%“ max_width_mobile=“default“][\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row][vc_row type=“full_width_background“ full_screen_row_position=“middle“ column_margin=“default“ equal_height=“yes“ column_direction=“default“ column_direction_tablet=“default“ column_direction_phone=“default“ bg_color=“#ffffff“ scene_position=“center“ top_padding=“60″ bottom_padding=“0″ left_padding_desktop=“20″ right_padding_desktop=“20″ top_padding_tablet=“60″ bottom_padding_tablet=“60″ left_padding_tablet=“20″ right_padding_tablet=“20″ top_padding_phone=“40″ bottom_padding_phone=“40″ left_padding_phone=“20″ right_padding_phone=“20″ text_color=“dark“ text_align=“center“ row_border_radius=“none“ row_border_radius_applies=“bg“ class=“equal–height“ overlay_strength=“0.3″ gradient_direction=“left_to_right“ shape_divider_position=“bottom“ bg_image_animation=“none“ shape_type=““][vc_column column_padding=“no-extra-padding“ column_padding_tablet=“inherit“ column_padding_phone=“inherit“ column_padding_position=“all“ bottom_margin=“40″ column_element_spacing=“default“ background_color_opacity=“1″ background_hover_color_opacity=“1″ column_shadow=“none“ column_border_radius=“none“ column_link_target=“_self“ gradient_direction=“left_to_right“ overlay_strength=“0.3″ width=“1\/1″ tablet_width_inherit=“default“ tablet_text_alignment=“default“ phone_text_alignment=“default“ bg_image_animation=“none“ border_type=“simple“ column_border_width=“none“ column_border_style=“solid“][vc_column_text]\n

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Vereinfachung des regulatorischen Prozesses<\/span><\/h3>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n[\/vc_column_text][vc_row_inner equal_height=“yes“ content_placement=“middle“ column_margin=“default“ column_direction=“default“ column_direction_tablet=“default“ column_direction_phone=“default“ top_padding=“60″ bottom_padding=“60″ left_padding_desktop=“20″ right_padding_desktop=“20″ text_align=“left“ class=“equal–height“][vc_column_inner column_padding=“no-extra-padding“ column_padding_tablet=“inherit“ column_padding_phone=“inherit“ column_padding_position=“all“ column_element_spacing=“default“ background_color_opacity=“1″ background_hover_color_opacity=“1″ column_shadow=“none“ column_border_radius=“none“ column_link_target=“_self“ gradient_direction=“left_to_right“ overlay_strength=“0.3″ width=“5\/12″ tablet_width_inherit=“default“ bg_image_animation=“none“ border_type=“simple“ column_border_width=“none“ column_border_style=“solid“][vc_column_text]Unsere Erfahrung
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Einreichungen von klinischen Pr\u00fcfungsantr\u00e4gen \u00fcber CTIS, Anfragen (RFIs) werden bei uns nat\u00fcrlich innerhalb der Frist beantwortet<\/span><\/p>\n

CTIS-Einreichungen werden gr\u00fcndlich durchgef\u00fchrt<\/span><\/p>\n

Unsere Experten f\u00fcr regulatorische Angelegenheiten werden stetig intensiv geschult und auch unser gesamtes Team erhalten grundlegende Trainings<\/span><\/p>\n<\/div>\n<\/div>\n<\/div>\n[\/vc_column_text][\/vc_column_inner][vc_column_inner column_padding=“no-extra-padding“ column_padding_tablet=“inherit“ column_padding_phone=“inherit“ column_padding_position=“all“ column_element_spacing=“default“ centered_text=“true“ background_color_opacity=“1″ background_hover_color_opacity=“1″ column_shadow=“none“ column_border_radius=“none“ column_link_target=“_self“ gradient_direction=“left_to_right“ overlay_strength=“0.3″ width=“1\/6″ tablet_width_inherit=“default“ bg_image_animation=“none“ border_type=“simple“ column_border_width=“none“ column_border_style=“solid“][\/vc_column_inner][vc_column_inner column_padding=“no-extra-padding“ column_padding_tablet=“inherit“ column_padding_phone=“inherit“ column_padding_position=“all“ column_element_spacing=“default“ background_color_opacity=“1″ background_hover_color_opacity=“1″ column_shadow=“none“ column_border_radius=“none“ column_link_target=“_self“ gradient_direction=“left_to_right“ overlay_strength=“0.3″ width=“5\/12″ tablet_width_inherit=“default“ bg_image_animation=“none“ border_type=“simple“ column_border_width=“none“ column_border_style=“solid“][vc_column_text]\n

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Besser eine Woche f\u00fcr die Planung hinzuf\u00fcgen, als einen Monat f\u00fcr \u00dcberarbeitungen verschwenden<\/strong><\/span><\/p>\n

Um die Pr\u00fcf- und Genehmigungsfristen zu verk\u00fcrzen und unn\u00f6tige Anfragen zu vermeiden, ist die Einreichung eines vollst\u00e4ndigen und qualitativ hochwertigen Dossiers von besonderer Bedeutung<\/span><\/p>\n

Vermeiden Sie last-minute \u00c4nderungen und Entscheidungen<\/span><\/p>\n

Wir setzten proaktive Anfragen um, bevor die Zentren danach fragen<\/span><\/p>\n<\/div>\n<\/div>\n<\/div>\n[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row][vc_row type=“full_width_background“ full_screen_row_position=“middle“ column_margin=“default“ column_direction=“default“ column_direction_tablet=“default“ column_direction_phone=“default“ bg_color=“#d0e7e9″ scene_position=“center“ top_padding=“60″ bottom_padding=“60″ left_padding_desktop=“20″ right_padding_desktop=“20″ top_padding_tablet=“60″ bottom_padding_tablet=“60″ left_padding_tablet=“20″ right_padding_tablet=“20″ top_padding_phone=“40″ bottom_padding_phone=“40″ left_padding_phone=“20″ right_padding_phone=“20″ text_color=“dark“ text_align=“center“ row_border_radius=“none“ row_border_radius_applies=“bg“ overlay_strength=“0.3″ gradient_direction=“left_to_right“ shape_divider_position=“bottom“ bg_image_animation=“none“ shape_type=““][vc_column column_padding=“no-extra-padding“ column_padding_tablet=“inherit“ column_padding_phone=“inherit“ column_padding_position=“all“ column_element_spacing=“default“ background_color_opacity=“1″ background_hover_color_opacity=“1″ column_shadow=“none“ column_border_radius=“none“ column_link_target=“_self“ gradient_direction=“left_to_right“ overlay_strength=“0.3″ width=“1\/1″ tablet_width_inherit=“default“ tablet_text_alignment=“default“ phone_text_alignment=“default“ bg_image_animation=“none“ border_type=“simple“ column_border_width=“none“ column_border_style=“solid“][vc_column_text]\n

Regulatorische Zeitpl\u00e4ne in CTIS<\/h3>\n[\/vc_column_text][divider line_type=“No Line“][vc_row_inner equal_height=“yes“ content_placement=“top“ column_margin=“default“ column_direction=“default“ column_direction_tablet=“default“ column_direction_phone=“default“ text_align=“left“ class=“equal–height“][vc_column_inner column_padding=“no-extra-padding“ column_padding_tablet=“inherit“ column_padding_phone=“inherit“ column_padding_position=“all“ column_element_spacing=“default“ background_color_opacity=“1″ background_hover_color_opacity=“1″ column_shadow=“none“ column_border_radius=“none“ column_link_target=“_self“ gradient_direction=“left_to_right“ overlay_strength=“0.3″ width=“1\/1″ tablet_width_inherit=“default“ bg_image_animation=“none“ border_type=“simple“ column_border_width=“none“ column_border_style=“solid“][image_with_animation image_url=“2842″ animation=“Fade In“ hover_animation=“none“ alignment=““ border_radius=“none“ box_shadow=“none“ image_loading=“default“ max_width=“100%“ max_width_mobile=“default“][\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row][vc_row type=“full_width_background“ full_screen_row_position=“middle“ column_margin=“default“ column_direction=“default“ column_direction_tablet=“default“ column_direction_phone=“default“ scene_position=“center“ top_padding=“40″ bottom_padding=“40″ left_padding_desktop=“20″ right_padding_desktop=“20″ top_padding_phone=“20″ bottom_padding_phone=“20″ left_padding_phone=“20″ right_padding_phone=“20″ text_color=“dark“ text_align=“left“ row_border_radius=“none“ row_border_radius_applies=“bg“ id=“ContactService“ overlay_strength=“0.3″ gradient_direction=“left_to_right“ shape_divider_position=“bottom“ bg_image_animation=“none“ shape_type=““][vc_column column_padding=“no-extra-padding“ column_padding_tablet=“inherit“ column_padding_phone=“inherit“ column_padding_position=“all“ left_margin=“auto“ right_margin=“auto“ left_margin_tablet=“auto“ right_margin_tablet=“auto“ left_margin_phone=“auto“ right_margin_phone=“auto“ column_element_spacing=“default“ background_color_opacity=“1″ background_hover_color_opacity=“1″ column_shadow=“none“ column_border_radius=“none“ column_link_target=“_self“ gradient_direction=“left_to_right“ overlay_strength=“0.3″ width=“1\/1″ tablet_width_inherit=“default“ tablet_text_alignment=“default“ phone_text_alignment=“default“ bg_image_animation=“none“ border_type=“simple“ column_border_width=“none“ column_border_style=“solid“][vc_column_text]\n
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Kontaktieren Sie uns jetzt f\u00fcr weitere Informationen<\/span><\/h3>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n[\/vc_column_text][vc_column_text]