{"id":1535,"date":"2025-11-28T05:28:12","date_gmt":"2025-11-28T05:28:12","guid":{"rendered":"https:\/\/bxplant.mycafe24.com\/expertise\/"},"modified":"2026-03-25T04:49:52","modified_gmt":"2026-03-25T04:49:52","slug":"expertise","status":"publish","type":"page","link":"https:\/\/bxplant.co.kr\/ko\/expertise\/","title":{"rendered":"Expertise"},"content":{"rendered":"[vc_row type=&#8221;in_container&#8221; full_screen_row_position=&#8221;middle&#8221; column_margin=&#8221;default&#8221; equal_height=&#8221;yes&#8221; content_placement=&#8221;bottom&#8221; column_direction=&#8221;default&#8221; column_direction_tablet=&#8221;default&#8221; column_direction_phone=&#8221;default&#8221; scene_position=&#8221;center&#8221; top_padding=&#8221;150px&#8221; bottom_padding=&#8221;10px&#8221; top_padding_tablet=&#8221;100px&#8221; top_padding_phone=&#8221;70px&#8221; text_color=&#8221;dark&#8221; text_align=&#8221;left&#8221; row_border_radius=&#8221;none&#8221; row_border_radius_applies=&#8221;bg&#8221; 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font_line_height=&#8221;1.3&#8243; text_direction=&#8221;default&#8221; font_size=&#8221;24&#8243; font_size_phone=&#8221;22&#8243;][\/split_line_heading]<div class=\"nectar-fancy-ul font_size_desktop_18px font_line_height_1-5\" data-list-icon=\"icon-salient-check\" data-animation=\"false\" data-animation-delay=\"0\" data-color=\"extra-color-2\" data-spacing=\"default\" data-alignment=\"left\"> <strong>Core Services<\/strong><\/p>\n<ul>\n<li><strong>Phase 1 Clinical Pharmacology<\/strong><br \/>\n&#8211; \ucd5c\ucd08 \uc778\uccb4 \ud22c\uc5ec(FIH) \uc2dc\ud5d8 \uc124\uacc4: \ub2e8\ud68c \ud22c\uc5ec \uc6a9\ub7c9 \uc99d\ub7c9(SAD), \ubc18\ubcf5 \ud22c\uc5ec \uc6a9\ub7c9 \uc99d\ub7c9(MAD), PK\/PD \ud2b9\uc131 \ud3c9\uac00<br \/>\n&#8211; ADME \uc2dc\ud5d8: \uc0dd\uccb4\uc774\uc6a9\ub960, \uc74c\uc2dd \uc601\ud5a5, \uc57d\ubb3c\uc0c1\ud638\uc791\uc6a9(DDI)<br \/>\n&#8211; \ud2b9\uc218 \uc9d1\ub2e8 \uc57d\ub3d9\ud559: \uc2e0\uc7a5\/\uac04 \uae30\ub2a5 \uc7a5\uc560, \uace0\ub839\uc790, \uc18c\uc544<br \/>\n&#8211; \uc0dd\ubb3c\ud559\uc801 \ub3d9\ub4f1\uc131 \ubc0f \ubc14\uc774\uc624\uc2dc\ubc00\ub7ec \ub3d9\ub4f1\uc131 \uc2dc\ud5d8<\/li>\n<li><strong>Phase 2-3 Clinical Development<\/strong><br \/>\n&#8211; \uac1c\ub150\uc99d\uba85(POC) \ubc0f \uc6a9\ub7c9 \ud0d0\uc0c9 \uc784\uc0c1\uc2dc\ud5d8<br \/>\n&#8211; \ud488\ubaa9\ud5c8\uac00\ub97c \uc704\ud55c \ud575\uc2ec \uc720\ud6a8\uc131\u00b7\uc548\uc804\uc131 \uc2dc\ud5d8(Pivotal Study)<br \/>\n&#8211; \uae00\ub85c\ubc8c \ub2e4\uad6d\uac00 \uc784\uc0c1\uc2dc\ud5d8(MRCT)<br \/>\n&#8211; \uc801\uc751\uc801 \uc124\uacc4(Adaptive Design) \ubc0f \uc784\uc0c1 \ub2e8\uacc4 \uac04 \uc6d0\ud65c\ud55c \uc804\ud658 \uc804\ub7b5<\/li>\n<li><strong>Regulatory Strategy &amp; Submissions<\/strong><br \/>\n&#8211; IND\/CTA \uc900\ube44 \ubc0f \uaddc\uc81c\uae30\uad00 \uc0ac\uc804 \uc0c1\ub2f4<br \/>\n&#8211; \ud488\ubaa9\ud5c8\uac00 \uc2e0\uccad(NDA\/BLA\/MAA) \uc9c0\uc6d0<br \/>\n&#8211; \uaddc\uc81c\uae30\uad00 \uacb0\ud568\uc0ac\ud56d(Deficiency) \ub300\uc751 \ubc0f \uc790\ubb38\uc704\uc6d0\ud68c \uc900\ube44<br \/>\n&#8211; \uc2e0\uc18d\uc2ec\uc0ac \uacbd\ub85c: \ud601\uc2e0\uce58\ub8cc\uc81c(Breakthrough Therapy), \ud328\uc2a4\ud2b8\ud2b8\ub799(Fast Track), PRIME \uc9c0\uc815<\/li>\n<li><strong>Small Molecule &amp; Antibody Expertise<\/strong><br \/>\n&#8211; \ub2e8\ud074\ub860\ud56d\uccb4(mAb) \ubc0f \ud56d\uccb4-\uc57d\ubb3c \uc811\ud569\uccb4(ADC)<br \/>\n&#8211; \uc774\uc911\ud2b9\uc774\uc131 \ud56d\uccb4(Bispecific Antibody) \ubc0f \ub2e4\uc911\ud2b9\uc774\uc131 \ud56d\uccb4 \uad6c\uc870\uccb4<br \/>\n&#8211; \uc735\ud569\ub2e8\ubc31\uc9c8(Fusion Protein) \ubc0f \uc7ac\uc870\ud569 \uce58\ub8cc\uc81c<br \/>\n&#8211; \uc2e0\uaddc \uc81c\ud615 \ubc0f \uc57d\ubb3c\uc804\ub2ec\uc2dc\uc2a4\ud15c(DDS)<\/li>\n<\/ul>\n <\/div>[\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row][vc_row type=&#8221;full_width_background&#8221; full_screen_row_position=&#8221;middle&#8221; column_margin=&#8221;default&#8221; column_direction=&#8221;default&#8221; column_direction_tablet=&#8221;default&#8221; column_direction_phone=&#8221;default&#8221; 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column_border_radius=&#8221;none&#8221; column_link_target=&#8221;_self&#8221; overflow=&#8221;visible&#8221; gradient_direction=&#8221;radial&#8221; overlay_strength=&#8221;0.3&#8243; width=&#8221;3\/5&#8243; tablet_width_inherit=&#8221;default&#8221; animation_type=&#8221;default&#8221; bg_image_animation=&#8221;none&#8221; parallax_bg=&#8221;true&#8221; parallax_bg_speed=&#8221;very_subtle&#8221; border_type=&#8221;simple&#8221; column_border_width=&#8221;none&#8221; column_border_style=&#8221;solid&#8221;][split_line_heading animation_type=&#8221;line-reveal-by-space&#8221; font_style=&#8221;h2&#8243; line_reveal_by_space_text_effect=&#8221;default&#8221; stagger_animation=&#8221;true&#8221; content_alignment=&#8221;default&#8221; mobile_content_alignment=&#8221;inherit&#8221; link_target=&#8221;_self&#8221; text_content=&#8221;Advanced Therapy Products&#8221; max_width=&#8221;500&#8243; text_direction=&#8221;default&#8221; font_line_height=&#8221;1.3&#8243; font_size=&#8221;40&#8243; font_size_phone=&#8221;28&#8243;][\/split_line_heading][split_line_heading animation_type=&#8221;line-reveal-by-space&#8221; font_style=&#8221;h5&#8243; line_reveal_by_space_text_effect=&#8221;default&#8221; stagger_animation=&#8221;true&#8221; content_alignment=&#8221;default&#8221; mobile_content_alignment=&#8221;inherit&#8221; link_target=&#8221;_self&#8221; text_content=&#8221;\uc778\uccb4\uc138\ud3ec\u00b7\uc870\uc9c1 \uae30\ubc18 \uce58\ub8cc\uc81c\uc758 \uc7a5\uae30\ucd94\uc801\uc870\uc0ac\u00b7\uc2dc\ud310 \ud6c4 \uc548\uc804\uad00\ub9ac\u00b7\ud5c8\uac00\uc804\ub7b5\uae4c\uc9c0 \uc804\ubb38\uc801\uc73c\ub85c \uc218\ud589&#8221; max_width=&#8221;550&#8243; font_line_height=&#8221;1.3&#8243; text_direction=&#8221;default&#8221; font_size=&#8221;24&#8243; font_size_phone=&#8221;22&#8243;][\/split_line_heading]<div class=\"nectar-fancy-ul font_size_desktop_18px font_line_height_1-5\" data-list-icon=\"icon-salient-check\" data-animation=\"false\" data-animation-delay=\"0\" data-color=\"extra-color-2\" data-spacing=\"default\" data-alignment=\"left\"> <strong>Core Services<\/strong><\/p>\n<ul>\n<li><strong>ATMP Development Strategy<\/strong><br \/>\n&#8211; \uc138\ud3ec\uce58\ub8cc\uc81c(CAR-T, TIL, MSC, iPSC \uc720\ub798) \uc784\uc0c1 \uac1c\ubc1c<br \/>\n&#8211; \uc720\uc804\uc790\uce58\ub8cc\uc81c(AAV, \ub80c\ud2f0\ubc14\uc774\ub7ec\uc2a4, \ube44\ubc14\uc774\ub7ec\uc2a4\uc131 \ubca1\ud130) \ud504\ub85c\uadf8\ub7a8 \uc124\uacc4<br \/>\n&#8211; \uc870\uc9c1\uacf5\ud559\uc81c\ud488 \ubc0f \uc7ac\uc0dd\uc758\ub8cc \uc804\ub7b5 \uc218\ub9bd<br \/>\n&#8211; \uc81c\uc870 \ub3d9\ub4f1\uc131 \ud3c9\uac00 \ubc0f CMC-\uc784\uc0c1 \uac00\uad50 \uc804\ub7b5<\/li>\n<li><strong>Long-Term Safety Monitoring<\/strong><br \/>\n&#8211; \uc7a5\uae30\ucd94\uc801\uc870\uc0ac(LTFU) \ud504\ub85c\ud1a0\ucf5c \uc124\uacc4 \ubc0f \uc6b4\uc601 (\ucd5c\ub300 15\ub144)<br \/>\n&#8211; ATMP \uc704\ud5d8\uad00\ub9ac \ubc0f \uc870\uc0ac(ARMI) \ud504\ub808\uc784\uc6cc\ud06c \uc774\ud589<br \/>\n&#8211; \uc9c0\uc5f0 \uc774\uc0c1\uc0ac\ub840 \ubaa8\ub2c8\ud130\ub9c1 \ubc0f \ubcf4\uace0 \uccb4\uacc4 \uad6c\ucd95<br \/>\n&#8211; \uad6d\uac00 \ub808\uc9c0\uc2a4\ud2b8\ub9ac \ubc0f \uac10\uc2dc \ub124\ud2b8\uc6cc\ud06c \uc5f0\uacc4<\/li>\n<li><strong>Specialized Study Management<\/strong><br \/>\n&#8211; \uc5f0\uad6c\uc790 \uc8fc\ub3c4 LTFU \uc2dc\ud5d8 \uc6b4\uc601 \ubc0f \uc784\uc0c1\uae30\uad00 \uc870\uc815<br \/>\n&#8211; \ud658\uc790 \ub808\uc9c0\uc2a4\ud2b8\ub9ac \uad6c\ucd95, \ub4f1\ub85d \uad00\ub9ac \ubc0f \uc7a5\uae30 \ub370\uc774\ud130 \uc218\uc9d1<br \/>\n&#8211; \uc2dc\ud310 \ud6c4 \uc870\uac74\ubd80 \uc774\ud589(PMC) \uc2dc\ud5d8 \uc124\uacc4 \ubc0f \uc6b4\uc601<br \/>\n&#8211; ATMP \uc0dd\uc560\uc8fc\uae30 \uad00\ub9ac\ub97c \uc704\ud55c \uc2e4\uc0ac\uc6a9\uc99d\uac70(RWE) \uc0dd\uc131<\/li>\n<li><strong>Regulatory Navigation<\/strong><br \/>\n&#8211; RMAT\/PRIME\/SAKIGAKE \uc9c0\uc815 \ubc0f \uc2e0\uc18d\ud5c8\uac00 \uacbd\ub85c \ud65c\uc6a9<br \/>\n&#8211; \uc81c\uc870 \ubcc0\uacbd\uc5d0 \ub530\ub978 \uc5ed\uac00(Potency) \ubc0f \ub3d9\ub4f1\uc131 \uc804\ub7b5 \uc218\ub9bd<br \/>\n&#8211; \uc870\uac74\ubd80 \ud5c8\uac00 \ubc0f \ud5c8\uac00 \ud6c4 \uc548\uc804\uc131 \uc5f0\uad6c(PASS) \uacc4\ud68d \uc218\ub9bd<br \/>\n&#8211; \uc18c\uc544 \uc784\uc0c1\uc2dc\ud5d8\uacc4\ud68d(PIP) \ubc0f \uc678\uc0bd(Extrapolation) \uc804\ub7b5 \uc218\ub9bd<\/li>\n<\/ul>\n <\/div>[\/vc_column_inner][vc_column_inner column_padding=&#8221;padding-4-percent&#8221; column_padding_tablet=&#8221;no-extra-padding&#8221; column_padding_phone=&#8221;no-extra-padding&#8221; column_padding_position=&#8221;all&#8221; column_element_direction_desktop=&#8221;default&#8221; column_element_spacing=&#8221;default&#8221; desktop_text_alignment=&#8221;default&#8221; tablet_text_alignment=&#8221;default&#8221; phone_text_alignment=&#8221;default&#8221; background_color_opacity=&#8221;1&#8243; background_hover_color_opacity=&#8221;1&#8243; column_backdrop_filter=&#8221;none&#8221; column_shadow=&#8221;none&#8221; column_border_radius=&#8221;none&#8221; column_link_target=&#8221;_self&#8221; overflow=&#8221;visible&#8221; gradient_direction=&#8221;left_to_right&#8221; overlay_strength=&#8221;0.3&#8243; width=&#8221;2\/5&#8243; tablet_width_inherit=&#8221;default&#8221; animation_type=&#8221;default&#8221; enable_animation=&#8221;true&#8221; animation=&#8221;fade-in-from-bottom&#8221; animation_easing=&#8221;default&#8221; bg_image_animation=&#8221;none&#8221; border_type=&#8221;simple&#8221; column_border_width=&#8221;none&#8221; column_border_style=&#8221;solid&#8221; column_padding_type=&#8221;default&#8221; gradient_type=&#8221;default&#8221; delay=&#8221;400&#8243;][image_with_animation image_url=&#8221;825&#8243; image_size=&#8221;full&#8221; animation_type=&#8221;entrance&#8221; animation=&#8221;None&#8221; animation_movement_type=&#8221;transform_y&#8221; animation_movement_intensity=&#8221;1.5&#8243; hover_animation=&#8221;none&#8221; alignment=&#8221;&#8221; border_radius=&#8221;custom&#8221; box_shadow=&#8221;none&#8221; top_left_border_radius=&#8221;0&#8243; top_right_border_radius=&#8221;0&#8243; bottom_right_border_radius=&#8221;50&#8243; bottom_left_border_radius=&#8221;0&#8243; image_loading=&#8221;default&#8221; max_width=&#8221;100%&#8221; max_width_mobile=&#8221;default&#8221;][\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row][vc_row type=&#8221;full_width_background&#8221; full_screen_row_position=&#8221;middle&#8221; column_margin=&#8221;default&#8221; column_direction=&#8221;default&#8221; column_direction_tablet=&#8221;default&#8221; column_direction_phone=&#8221;default&#8221; bg_color=&#8221;#ffffff&#8221; scene_position=&#8221;center&#8221; left_padding_desktop=&#8221;5%&#8221; constrain_group_2=&#8221;yes&#8221; right_padding_desktop=&#8221;5%&#8221; top_padding_tablet=&#8221;8%&#8221; constrain_group_3=&#8221;yes&#8221; bottom_padding_tablet=&#8221;8%&#8221; left_padding_phone=&#8221;0&#8243; constrain_group_6=&#8221;yes&#8221; right_padding_phone=&#8221;0&#8243; text_color=&#8221;dark&#8221; text_align=&#8221;left&#8221; row_border_radius=&#8221;none&#8221; row_border_radius_applies=&#8221;bg&#8221; overflow=&#8221;visible&#8221; id=&#8221;MedicalDevice&#8221; overlay_strength=&#8221;0.3&#8243; gradient_direction=&#8221;left_to_right&#8221; shape_divider_position=&#8221;bottom&#8221; bg_image_animation=&#8221;none&#8221; shape_type=&#8221;&#8221; gradient_type=&#8221;default&#8221;][vc_column column_padding=&#8221;no-extra-padding&#8221; column_padding_tablet=&#8221;inherit&#8221; column_padding_phone=&#8221;inherit&#8221; column_padding_position=&#8221;all&#8221; column_element_direction_desktop=&#8221;default&#8221; column_element_spacing=&#8221;default&#8221; desktop_text_alignment=&#8221;default&#8221; tablet_text_alignment=&#8221;default&#8221; phone_text_alignment=&#8221;default&#8221; background_color_opacity=&#8221;1&#8243; background_hover_color_opacity=&#8221;1&#8243; column_backdrop_filter=&#8221;none&#8221; column_shadow=&#8221;none&#8221; column_border_radius=&#8221;none&#8221; column_link_target=&#8221;_self&#8221; column_position=&#8221;default&#8221; gradient_direction=&#8221;left_to_right&#8221; overlay_strength=&#8221;0.3&#8243; width=&#8221;1\/1&#8243; tablet_width_inherit=&#8221;default&#8221; animation_type=&#8221;default&#8221; bg_image_animation=&#8221;none&#8221; border_type=&#8221;simple&#8221; column_border_width=&#8221;none&#8221; column_border_style=&#8221;solid&#8221;][vc_row_inner equal_height=&#8221;yes&#8221; content_placement=&#8221;middle&#8221; column_margin=&#8221;60px&#8221; column_direction=&#8221;default&#8221; column_direction_tablet=&#8221;default&#8221; column_direction_phone=&#8221;default&#8221; text_align=&#8221;left&#8221; row_position=&#8221;default&#8221; row_position_tablet=&#8221;inherit&#8221; row_position_phone=&#8221;inherit&#8221; overflow=&#8221;visible&#8221; pointer_events=&#8221;all&#8221;][vc_column_inner column_padding=&#8221;padding-4-percent&#8221; column_padding_tablet=&#8221;no-extra-padding&#8221; column_padding_phone=&#8221;no-extra-padding&#8221; column_padding_position=&#8221;all&#8221; column_element_direction_desktop=&#8221;default&#8221; column_element_spacing=&#8221;default&#8221; desktop_text_alignment=&#8221;default&#8221; tablet_text_alignment=&#8221;default&#8221; phone_text_alignment=&#8221;default&#8221; background_color_opacity=&#8221;1&#8243; background_hover_color_opacity=&#8221;1&#8243; column_backdrop_filter=&#8221;none&#8221; column_shadow=&#8221;none&#8221; column_border_radius=&#8221;none&#8221; column_link_target=&#8221;_self&#8221; overflow=&#8221;visible&#8221; gradient_direction=&#8221;left_to_right&#8221; overlay_strength=&#8221;0.3&#8243; width=&#8221;2\/5&#8243; tablet_width_inherit=&#8221;default&#8221; animation_type=&#8221;default&#8221; enable_animation=&#8221;true&#8221; animation=&#8221;fade-in-from-bottom&#8221; animation_easing=&#8221;default&#8221; bg_image_animation=&#8221;none&#8221; border_type=&#8221;simple&#8221; column_border_width=&#8221;none&#8221; column_border_style=&#8221;solid&#8221; column_padding_type=&#8221;default&#8221; gradient_type=&#8221;default&#8221; delay=&#8221;400&#8243;][image_with_animation image_url=&#8221;1382&#8243; image_size=&#8221;full&#8221; animation_type=&#8221;entrance&#8221; animation=&#8221;None&#8221; animation_movement_type=&#8221;transform_y&#8221; animation_movement_intensity=&#8221;1.5&#8243; hover_animation=&#8221;none&#8221; alignment=&#8221;&#8221; border_radius=&#8221;custom&#8221; box_shadow=&#8221;none&#8221; top_left_border_radius=&#8221;0&#8243; top_right_border_radius=&#8221;0&#8243; bottom_right_border_radius=&#8221;0&#8243; bottom_left_border_radius=&#8221;50&#8243; image_loading=&#8221;default&#8221; max_width=&#8221;100%&#8221; max_width_mobile=&#8221;default&#8221;][\/vc_column_inner][vc_column_inner column_padding=&#8221;padding-4-percent&#8221; column_padding_tablet=&#8221;inherit&#8221; column_padding_phone=&#8221;no-extra-padding&#8221; column_padding_position=&#8221;all&#8221; top_margin=&#8221;6%&#8221; top_margin_tablet=&#8221;0&#8243; top_margin_phone=&#8221;4%&#8221; column_element_direction_desktop=&#8221;default&#8221; column_element_spacing=&#8221;default&#8221; desktop_text_alignment=&#8221;default&#8221; tablet_text_alignment=&#8221;default&#8221; phone_text_alignment=&#8221;default&#8221; background_color_opacity=&#8221;1&#8243; background_hover_color_opacity=&#8221;1&#8243; column_backdrop_filter=&#8221;none&#8221; column_shadow=&#8221;none&#8221; column_border_radius=&#8221;none&#8221; column_link_target=&#8221;_self&#8221; overflow=&#8221;visible&#8221; gradient_direction=&#8221;left_to_right&#8221; overlay_strength=&#8221;0.3&#8243; width=&#8221;3\/5&#8243; tablet_width_inherit=&#8221;default&#8221; animation_type=&#8221;default&#8221; bg_image_animation=&#8221;none&#8221; parallax_bg=&#8221;true&#8221; parallax_bg_speed=&#8221;fast&#8221; border_type=&#8221;simple&#8221; column_border_width=&#8221;none&#8221; column_border_style=&#8221;solid&#8221;][split_line_heading animation_type=&#8221;line-reveal-by-space&#8221; font_style=&#8221;h2&#8243; line_reveal_by_space_text_effect=&#8221;default&#8221; stagger_animation=&#8221;true&#8221; content_alignment=&#8221;default&#8221; mobile_content_alignment=&#8221;inherit&#8221; link_target=&#8221;_self&#8221; text_content=&#8221;Medical Devices&#8221; max_width=&#8221;400&#8243; font_line_height=&#8221;1.3&#8243; text_direction=&#8221;default&#8221; font_size=&#8221;40&#8243; font_size_phone=&#8221;28&#8243;][\/split_line_heading][split_line_heading animation_type=&#8221;line-reveal-by-space&#8221; font_style=&#8221;h5&#8243; line_reveal_by_space_text_effect=&#8221;default&#8221; stagger_animation=&#8221;true&#8221; content_alignment=&#8221;default&#8221; mobile_content_alignment=&#8221;inherit&#8221; link_target=&#8221;_self&#8221; text_content=&#8221;\uc5d0\uc2a4\ud14c\ud2f1\ubd80\ud130 AI \uae30\ubc18 Software, Digital Therapeutics\uae4c\uc9c0 \ub2e4\uc591\ud55c \uae30\uae30\uc758 \uc784\uc0c1\u00b7\uc2e4\uc99d\u00b7RA\ub97c \uc218\ud589&#8221; max_width=&#8221;550&#8243; font_line_height=&#8221;1.3&#8243; text_direction=&#8221;default&#8221; font_size=&#8221;24&#8243; font_size_phone=&#8221;22&#8243;][\/split_line_heading]<div class=\"nectar-fancy-ul font_size_desktop_18px font_line_height_1-5\" data-list-icon=\"icon-salient-check\" data-animation=\"false\" data-animation-delay=\"0\" data-color=\"extra-color-2\" data-spacing=\"default\" data-alignment=\"left\"> <strong>Core Services<\/strong><\/p>\n<ul>\n<li><strong>Device Expertise Across Modalities<\/strong><br \/>\n&#8211; \ubbf8\uc6a9\u00b7\uc131\ud615 \uae30\uae30: \ud544\ub7ec, \ubcf4\ud234\ub9ac\ub214 \ub3c5\uc18c, \ub9ac\ud504\ud305 \uc2e4, \ub808\uc774\uc800, \uc5d0\ub108\uc9c0 \uae30\ubc18 \uae30\uae30(RF, \ucd08\uc74c\ud30c, \ub0c9\ub3d9\uce58\ub8cc)<br \/>\n&#8211; \ub514\uc9c0\ud138 \ud5ec\uc2a4: AI\/ML \uae30\ubc18 \uc18c\ud504\ud2b8\uc6e8\uc5b4 \uc758\ub8cc\uae30\uae30(SaMD), \uc6d0\uaca9 \ubaa8\ub2c8\ud130\ub9c1 \ud50c\ub7ab\ud3fc, \ucc98\ubc29\ud615 \ub514\uc9c0\ud138\uce58\ub8cc\uae30\uae30(DTx)<br \/>\n&#8211; \uce58\ub8cc\uc6a9 \uae30\uae30: \uc774\uc2dd\ud615 \uae30\uae30, \uc6e8\uc5b4\ub7ec\ube14, \uc2e0\uacbd \uc790\uadf9 \uae30\uae30, \ud1b5\uc99d \uad00\ub9ac \uc2dc\uc2a4\ud15c<\/li>\n<li><strong>Clinical Investigation Programs<\/strong><br \/>\n&#8211; \uaddc\uc81c \ud5c8\uac00 \uc2e0\uccad\uc744 \uc704\ud55c \uc548\uc804\uc131, \uc131\ub2a5 \ubc0f \uc720\ud6a8\uc131 \uc2dc\ud5d8<br \/>\n&#8211; CE \ub9c8\ud06c(EU MDR), FDA 510(k)\/PMA \ubc0f \uc2dd\uc57d\ucc98(MFDS) \ud5c8\uac00\ub97c \uc704\ud55c \ud575\uc2ec \uc784\uc0c1\uc2dc\ud5d8(Pivotal Trial)<br \/>\n&#8211; \uc2dc\ud310 \ud6c4 \uc784\uc0c1\ucd94\uc801\uc870\uc0ac(PMCF) \ubc0f \uc2e4\uc0ac\uc6a9 \uc131\ub2a5 \uc5f0\uad6c<br \/>\n&#8211; \ube44\uad50 \ud6a8\uacfc \uc5f0\uad6c \ubc0f \ube44\uc5f4\ub4f1\uc131 \uc124\uacc4<\/li>\n<li><strong>Regulatory Strategy &amp; Submissions<\/strong><br \/>\n&#8211; \uae30\uae30 \ubd84\ub958 \ubc0f \ucd5c\uc801 \uaddc\uc81c \uacbd\ub85c \uc120\uc815(FDA\/MDR\/MFDS\/PMDA)<br \/>\n&#8211; \uc784\uc0c1\ud3c9\uac00\ubcf4\uace0\uc11c(CER), \ub3d9\ub4f1\uc131 \ud3c9\uac00 \ubc0f \uac2d \ubd84\uc11d<br \/>\n&#8211; \uc0ac\uc804 \uc0c1\ub2f4(Pre-submission) \ubc0f \uacfc\ud559 \uc790\ubb38 \ubbf8\ud305<br \/>\n&#8211; \uae30\uc220 \ubb38\uc11c(Technical File) \uc900\ube44 \ubc0f \uc778\uc99d\uae30\uad00(Notified Body) \ub300\uc751<\/li>\n<li><strong>Study Operations &amp; Quality Assurance<\/strong><br \/>\n&#8211; \ub3c5\ub9bd\ud3c9\uac00\uc790(IE) \uc120\uc815 \ubc0f \ub9f9\uac80 \ud3c9\uac00 \uad00\ub9ac<br \/>\n&#8211; \uc0ac\uc9c4 \ucd2c\uc601 \ud504\ub85c\ud1a0\ucf5c \ubc0f \ud45c\uc900\ud654\ub41c \uacb0\uacfc \uce21\uc815<br \/>\n&#8211; \ud310\uc815\uc704\uc6d0\ud68c(Adjudication Committee) \uac10\ub3c5 \ubc0f \ud3c9\uac00\ubcc0\uc218 \uac80\uc99d<br \/>\n&#8211; GCP \uc900\uc218 \ubaa8\ub2c8\ud130\ub9c1 \ubc0f \uaddc\uc81c\uae30\uad00 \uc2e4\uc0ac \ub300\ube44<\/li>\n<\/ul>\n <\/div>[\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row][vc_row type=&#8221;full_width_background&#8221; full_screen_row_position=&#8221;middle&#8221; column_margin=&#8221;default&#8221; column_direction=&#8221;default&#8221; column_direction_tablet=&#8221;default&#8221; column_direction_phone=&#8221;default&#8221; bg_color=&#8221;#ffffff&#8221; scene_position=&#8221;center&#8221; left_padding_desktop=&#8221;5%&#8221; constrain_group_2=&#8221;yes&#8221; right_padding_desktop=&#8221;5%&#8221; top_padding_tablet=&#8221;8%&#8221; constrain_group_3=&#8221;yes&#8221; bottom_padding_tablet=&#8221;8%&#8221; left_padding_phone=&#8221;0&#8243; constrain_group_6=&#8221;yes&#8221; right_padding_phone=&#8221;0&#8243; text_color=&#8221;dark&#8221; text_align=&#8221;left&#8221; row_border_radius=&#8221;none&#8221; row_border_radius_applies=&#8221;bg&#8221; overflow=&#8221;visible&#8221; id=&#8221;IVD&#8221; overlay_strength=&#8221;0.3&#8243; gradient_direction=&#8221;left_to_right&#8221; shape_divider_position=&#8221;bottom&#8221; bg_image_animation=&#8221;none&#8221; shape_type=&#8221;&#8221; gradient_type=&#8221;default&#8221;][vc_column column_padding=&#8221;no-extra-padding&#8221; column_padding_tablet=&#8221;inherit&#8221; column_padding_phone=&#8221;inherit&#8221; column_padding_position=&#8221;all&#8221; column_element_direction_desktop=&#8221;default&#8221; column_element_spacing=&#8221;default&#8221; desktop_text_alignment=&#8221;default&#8221; tablet_text_alignment=&#8221;default&#8221; phone_text_alignment=&#8221;default&#8221; background_color_opacity=&#8221;1&#8243; background_hover_color_opacity=&#8221;1&#8243; column_backdrop_filter=&#8221;none&#8221; column_shadow=&#8221;none&#8221; column_border_radius=&#8221;none&#8221; column_link_target=&#8221;_self&#8221; column_position=&#8221;default&#8221; gradient_direction=&#8221;left_to_right&#8221; overlay_strength=&#8221;0.3&#8243; width=&#8221;1\/1&#8243; tablet_width_inherit=&#8221;default&#8221; animation_type=&#8221;default&#8221; bg_image_animation=&#8221;none&#8221; border_type=&#8221;simple&#8221; column_border_width=&#8221;none&#8221; column_border_style=&#8221;solid&#8221;][vc_row_inner equal_height=&#8221;yes&#8221; content_placement=&#8221;middle&#8221; column_margin=&#8221;60px&#8221; column_direction=&#8221;default&#8221; column_direction_tablet=&#8221;column_reverse&#8221; column_direction_phone=&#8221;column_reverse&#8221; text_align=&#8221;left&#8221; row_position=&#8221;default&#8221; row_position_tablet=&#8221;inherit&#8221; row_position_phone=&#8221;inherit&#8221; overflow=&#8221;visible&#8221; pointer_events=&#8221;all&#8221;][vc_column_inner column_padding=&#8221;padding-4-percent&#8221; column_padding_tablet=&#8221;inherit&#8221; column_padding_phone=&#8221;no-extra-padding&#8221; column_padding_position=&#8221;all&#8221; top_margin=&#8221;6%&#8221; top_margin_tablet=&#8221;0&#8243; top_margin_phone=&#8221;4%&#8221; column_element_direction_desktop=&#8221;default&#8221; column_element_spacing=&#8221;default&#8221; desktop_text_alignment=&#8221;default&#8221; tablet_text_alignment=&#8221;default&#8221; phone_text_alignment=&#8221;default&#8221; background_color_opacity=&#8221;1&#8243; background_hover_color_opacity=&#8221;1&#8243; column_backdrop_filter=&#8221;none&#8221; column_shadow=&#8221;none&#8221; column_border_radius=&#8221;none&#8221; column_link_target=&#8221;_self&#8221; overflow=&#8221;visible&#8221; gradient_direction=&#8221;radial&#8221; overlay_strength=&#8221;0.3&#8243; width=&#8221;3\/5&#8243; tablet_width_inherit=&#8221;default&#8221; animation_type=&#8221;default&#8221; bg_image_animation=&#8221;none&#8221; parallax_bg=&#8221;true&#8221; parallax_bg_speed=&#8221;very_subtle&#8221; border_type=&#8221;simple&#8221; column_border_width=&#8221;none&#8221; column_border_style=&#8221;solid&#8221;][split_line_heading animation_type=&#8221;line-reveal-by-space&#8221; font_style=&#8221;h2&#8243; line_reveal_by_space_text_effect=&#8221;default&#8221; stagger_animation=&#8221;true&#8221; content_alignment=&#8221;default&#8221; mobile_content_alignment=&#8221;inherit&#8221; link_target=&#8221;_self&#8221; text_content=&#8221;In Vitro Diagnostics&#8221; max_width=&#8221;400&#8243; text_direction=&#8221;default&#8221; font_line_height=&#8221;1.3&#8243; font_size=&#8221;40&#8243; font_size_phone=&#8221;28&#8243;][\/split_line_heading][split_line_heading animation_type=&#8221;line-reveal-by-space&#8221; font_style=&#8221;h5&#8243; line_reveal_by_space_text_effect=&#8221;default&#8221; stagger_animation=&#8221;true&#8221; content_alignment=&#8221;default&#8221; mobile_content_alignment=&#8221;inherit&#8221; link_target=&#8221;_self&#8221; text_content=&#8221;\uc131\ub2a5\ud3c9\uac00\ubd80\ud130 \ud5c8\uac00\uc6a9 \uc784\uc0c1\uc2e4\uc99d\uae4c\uc9c0 IVD Full-Cycle \uc9c0\uc6d0&#8221; max_width=&#8221;550&#8243; font_line_height=&#8221;1.3&#8243; text_direction=&#8221;default&#8221; font_size=&#8221;24&#8243; font_size_phone=&#8221;22&#8243;][\/split_line_heading]<div class=\"nectar-fancy-ul font_size_desktop_18px font_line_height_1-5\" data-list-icon=\"icon-salient-check\" data-animation=\"false\" data-animation-delay=\"0\" data-color=\"extra-color-2\" data-spacing=\"default\" data-alignment=\"left\"> <strong>Core Services<\/strong><\/p>\n<ul>\n<li><strong>IVD Expertise Across Diagnostic Platforms<\/strong><br \/>\n&#8211; \ub2e4\uc591\ud55c \ud50c\ub7ab\ud3fc \ubc0f \ubc29\ubc95\ub860\uc5d0 \uac78\uce5c \uc9c4\ub2e8 \uac80\uc0ac \uac1c\ubc1c<br \/>\n&#8211; \uc790\uccb4\uac1c\ubc1c\uac80\uc0ac(LDT) \ubc0f \uc0c1\uc5c5\uc6a9 \ubd84\uc11d\ubc95 \uac80\uc99d<br \/>\n&#8211; \uc815\ubc00\uc758\ub8cc \uc801\uc6a9\uc744 \uc704\ud55c \ub3d9\ubc18\uc9c4\ub2e8(CDx) \uac1c\ubc1c<\/li>\n<li><strong>Analytical Performance Evaluation<\/strong><br \/>\n&#8211; \ubd84\uc11d\uc801 \ubc38\ub9ac\ub370\uc774\uc158: \uc815\ubc00\ub3c4, \uc815\ud655\ub3c4, LoD\/LoQ, \uc9c1\uc120\uc131, \uac04\uc12d, \uc548\uc815\uc131<br \/>\n&#8211; \uac80\uc99d \uc2dc\ud5d8 \ubc0f \ubc29\ubc95 \ube44\uad50 \ud504\ub85c\ud1a0\ucf5c<br \/>\n&#8211; \uac80\uccb4 \uc218\uc9d1, \ucde8\uae09 \ubc0f \ubcf4\uad00 \uc870\uac74 \uac80\uc99d<\/li>\n<li><strong>Clinical Performance Studies<\/strong><br \/>\n&#8211; \uc784\uc0c1\uc801 \ubc38\ub9ac\ub370\uc774\uc158: \ubbfc\uac10\ub3c4, \ud2b9\uc774\ub3c4, \uc591\uc131\uc608\uce21\ub3c4(PPV)\/\uc74c\uc131\uc608\uce21\ub3c4(NPV), \uc9c4\ub2e8 \uc815\ud655\ub3c4<br \/>\n&#8211; \uc804\ud5a5\uc801\u00b7\ud6c4\ud5a5\uc801 \uc2dc\ud5d8 \uc124\uacc4 \ubc0f \uc6b4\uc601<br \/>\n&#8211; \uc0ac\uc6a9\ubaa9\uc801 \ud658\uc790\uad70 \uc2dc\ud5d8 \ubc0f \uc2e4\uc0ac\uc6a9 \uc784\uc0c1\uc801 \uc720\uc6a9\uc131 \ud3c9\uac00<\/li>\n<li><strong>Regulatory Strategy &amp; Submissions<\/strong><br \/>\n&#8211; FDA(510(k)\/De Novo\/PMA), IVDR(Class A-D), \uc2dd\uc57d\ucc98(MFDS), PMDA \ud5c8\uac00 \uacbd\ub85c \ucd5c\uc801\ud654<br \/>\n&#8211; \uc131\ub2a5\ud3c9\uac00\ubcf4\uace0\uc11c(PER) \uc791\uc131 \ubc0f \uc784\uc0c1\uc801 \uadfc\uac70 \ubb38\uc11c\ud654<br \/>\n&#8211; \ub3d9\ubc18\uc9c4\ub2e8(CDx) \uacf5\ub3d9 \uac1c\ubc1c \uc804\ub7b5 \ubc0f \ud601\uc2e0\uc758\ub8cc\uae30\uae30(Breakthrough Device) \uc9c0\uc815 \uc9c0\uc6d0<\/li>\n<\/ul>\n <\/div>[\/vc_column_inner][vc_column_inner column_padding=&#8221;padding-4-percent&#8221; column_padding_tablet=&#8221;no-extra-padding&#8221; column_padding_phone=&#8221;no-extra-padding&#8221; column_padding_position=&#8221;all&#8221; column_element_direction_desktop=&#8221;default&#8221; column_element_spacing=&#8221;default&#8221; desktop_text_alignment=&#8221;default&#8221; tablet_text_alignment=&#8221;default&#8221; phone_text_alignment=&#8221;default&#8221; background_color_opacity=&#8221;1&#8243; background_hover_color_opacity=&#8221;1&#8243; column_backdrop_filter=&#8221;none&#8221; column_shadow=&#8221;none&#8221; column_border_radius=&#8221;none&#8221; column_link_target=&#8221;_self&#8221; overflow=&#8221;visible&#8221; gradient_direction=&#8221;left_to_right&#8221; overlay_strength=&#8221;0.3&#8243; width=&#8221;2\/5&#8243; tablet_width_inherit=&#8221;default&#8221; animation_type=&#8221;default&#8221; enable_animation=&#8221;true&#8221; animation=&#8221;fade-in-from-bottom&#8221; animation_easing=&#8221;default&#8221; bg_image_animation=&#8221;none&#8221; border_type=&#8221;simple&#8221; column_border_width=&#8221;none&#8221; column_border_style=&#8221;solid&#8221; column_padding_type=&#8221;default&#8221; gradient_type=&#8221;default&#8221; delay=&#8221;400&#8243;][image_with_animation image_url=&#8221;1190&#8243; image_size=&#8221;full&#8221; animation_type=&#8221;entrance&#8221; animation=&#8221;None&#8221; animation_movement_type=&#8221;transform_y&#8221; animation_movement_intensity=&#8221;1.5&#8243; hover_animation=&#8221;none&#8221; alignment=&#8221;&#8221; border_radius=&#8221;custom&#8221; box_shadow=&#8221;none&#8221; top_left_border_radius=&#8221;0&#8243; top_right_border_radius=&#8221;0&#8243; bottom_right_border_radius=&#8221;50&#8243; bottom_left_border_radius=&#8221;0&#8243; image_loading=&#8221;default&#8221; max_width=&#8221;100%&#8221; max_width_mobile=&#8221;default&#8221;][\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row][vc_row type=&#8221;full_width_background&#8221; full_screen_row_position=&#8221;middle&#8221; column_margin=&#8221;default&#8221; column_direction=&#8221;default&#8221; column_direction_tablet=&#8221;default&#8221; column_direction_phone=&#8221;default&#8221; bg_color=&#8221;#ffffff&#8221; scene_position=&#8221;center&#8221; left_padding_desktop=&#8221;5%&#8221; constrain_group_2=&#8221;yes&#8221; right_padding_desktop=&#8221;5%&#8221; top_padding_tablet=&#8221;8%&#8221; constrain_group_3=&#8221;yes&#8221; bottom_padding_tablet=&#8221;8%&#8221; left_padding_phone=&#8221;0&#8243; constrain_group_6=&#8221;yes&#8221; right_padding_phone=&#8221;0&#8243; text_color=&#8221;dark&#8221; text_align=&#8221;left&#8221; row_border_radius=&#8221;none&#8221; row_border_radius_applies=&#8221;bg&#8221; overflow=&#8221;visible&#8221; id=&#8221;Post-Market&#8221; overlay_strength=&#8221;0.3&#8243; gradient_direction=&#8221;left_to_right&#8221; shape_divider_position=&#8221;bottom&#8221; bg_image_animation=&#8221;none&#8221; shape_type=&#8221;&#8221; gradient_type=&#8221;default&#8221;][vc_column column_padding=&#8221;no-extra-padding&#8221; column_padding_tablet=&#8221;inherit&#8221; column_padding_phone=&#8221;inherit&#8221; column_padding_position=&#8221;all&#8221; column_element_direction_desktop=&#8221;default&#8221; column_element_spacing=&#8221;default&#8221; desktop_text_alignment=&#8221;default&#8221; tablet_text_alignment=&#8221;default&#8221; phone_text_alignment=&#8221;default&#8221; background_color_opacity=&#8221;1&#8243; background_hover_color_opacity=&#8221;1&#8243; column_backdrop_filter=&#8221;none&#8221; column_shadow=&#8221;none&#8221; column_border_radius=&#8221;none&#8221; column_link_target=&#8221;_self&#8221; column_position=&#8221;default&#8221; gradient_direction=&#8221;left_to_right&#8221; overlay_strength=&#8221;0.3&#8243; width=&#8221;1\/1&#8243; tablet_width_inherit=&#8221;default&#8221; animation_type=&#8221;default&#8221; bg_image_animation=&#8221;none&#8221; border_type=&#8221;simple&#8221; column_border_width=&#8221;none&#8221; column_border_style=&#8221;solid&#8221;][vc_row_inner equal_height=&#8221;yes&#8221; content_placement=&#8221;middle&#8221; column_margin=&#8221;60px&#8221; column_direction=&#8221;default&#8221; column_direction_tablet=&#8221;default&#8221; column_direction_phone=&#8221;default&#8221; text_align=&#8221;left&#8221; row_position=&#8221;default&#8221; row_position_tablet=&#8221;inherit&#8221; row_position_phone=&#8221;inherit&#8221; overflow=&#8221;visible&#8221; pointer_events=&#8221;all&#8221;][vc_column_inner column_padding=&#8221;padding-4-percent&#8221; column_padding_tablet=&#8221;no-extra-padding&#8221; column_padding_phone=&#8221;no-extra-padding&#8221; column_padding_position=&#8221;all&#8221; column_element_direction_desktop=&#8221;default&#8221; column_element_spacing=&#8221;default&#8221; 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image_size=&#8221;full&#8221; animation_type=&#8221;entrance&#8221; animation=&#8221;None&#8221; animation_movement_type=&#8221;transform_y&#8221; animation_movement_intensity=&#8221;1.5&#8243; hover_animation=&#8221;none&#8221; alignment=&#8221;&#8221; border_radius=&#8221;custom&#8221; box_shadow=&#8221;none&#8221; top_left_border_radius=&#8221;0&#8243; top_right_border_radius=&#8221;0&#8243; bottom_right_border_radius=&#8221;0&#8243; bottom_left_border_radius=&#8221;50&#8243; image_loading=&#8221;default&#8221; max_width=&#8221;100%&#8221; max_width_mobile=&#8221;default&#8221;][\/vc_column_inner][vc_column_inner column_padding=&#8221;padding-4-percent&#8221; column_padding_tablet=&#8221;inherit&#8221; column_padding_phone=&#8221;no-extra-padding&#8221; column_padding_position=&#8221;all&#8221; top_margin=&#8221;6%&#8221; top_margin_tablet=&#8221;0&#8243; top_margin_phone=&#8221;4%&#8221; column_element_direction_desktop=&#8221;default&#8221; column_element_spacing=&#8221;default&#8221; desktop_text_alignment=&#8221;default&#8221; tablet_text_alignment=&#8221;default&#8221; phone_text_alignment=&#8221;default&#8221; background_color_opacity=&#8221;1&#8243; background_hover_color_opacity=&#8221;1&#8243; column_backdrop_filter=&#8221;none&#8221; column_shadow=&#8221;none&#8221; column_border_radius=&#8221;none&#8221; column_link_target=&#8221;_self&#8221; overflow=&#8221;visible&#8221; gradient_direction=&#8221;left_to_right&#8221; overlay_strength=&#8221;0.3&#8243; width=&#8221;3\/5&#8243; tablet_width_inherit=&#8221;default&#8221; animation_type=&#8221;default&#8221; bg_image_animation=&#8221;none&#8221; parallax_bg=&#8221;true&#8221; parallax_bg_speed=&#8221;fast&#8221; border_type=&#8221;simple&#8221; column_border_width=&#8221;none&#8221; column_border_style=&#8221;solid&#8221;][split_line_heading animation_type=&#8221;line-reveal-by-space&#8221; font_style=&#8221;h2&#8243; line_reveal_by_space_text_effect=&#8221;default&#8221; stagger_animation=&#8221;true&#8221; content_alignment=&#8221;default&#8221; mobile_content_alignment=&#8221;inherit&#8221; link_target=&#8221;_self&#8221; text_content=&#8221;Post-Market Surveillance &amp; Pharmacovigilance&#8221; max_width=&#8221;400&#8243; font_line_height=&#8221;1.3&#8243; text_direction=&#8221;default&#8221; font_size=&#8221;40&#8243; font_size_phone=&#8221;28&#8243;][\/split_line_heading][split_line_heading animation_type=&#8221;line-reveal-by-space&#8221; font_style=&#8221;h5&#8243; line_reveal_by_space_text_effect=&#8221;default&#8221; stagger_animation=&#8221;true&#8221; content_alignment=&#8221;default&#8221; mobile_content_alignment=&#8221;inherit&#8221; link_target=&#8221;_self&#8221; text_content=&#8221;\uc81c\ud488\uc758 \uc2dc\uc7a5 \ud3ec\uc9c0\uc154\ub2dd\uc744 \uc704\ud55c \uc0ac\uc6a9\uc131\u00b7\uace0\uac1d\uacbd\ud5d8\u00b7\uc6b0\uc6d4\uc131 \uae30\ubc18 \uc784\uc0c1 \ub514\uc790\uc778 \ud5c8\uac00 \ud6c4 \uc548\uc804\uc131\u00b7\uc720\ud6a8\uc131 \uadfc\uac70 \ud655\ubcf4\ub97c \uc704\ud55c \uc2dc\ud310 \ud6c4 \uc870\uc0ac\u00b7PMCF \uc804\ubb38 \uc9d1\ud589&#8221; max_width=&#8221;550&#8243; font_line_height=&#8221;1.3&#8243; text_direction=&#8221;default&#8221; font_size=&#8221;24&#8243; font_size_phone=&#8221;22&#8243;][\/split_line_heading]<div class=\"nectar-fancy-ul font_size_desktop_18px font_line_height_1-5\" data-list-icon=\"icon-salient-check\" data-animation=\"false\" data-animation-delay=\"0\" data-color=\"extra-color-2\" data-spacing=\"default\" data-alignment=\"left\"> <strong>Core Services<\/strong><\/p>\n<ul>\n<li><strong>Safety Monitoring Programs<\/strong><br \/>\n&#8211; \uc2dc\ud310 \ud6c4 \uc870\uc0ac(PMS) \ud504\ub85c\uadf8\ub7a8 \uc124\uacc4 \ubc0f \uc6b4\uc601<br \/>\n&#8211; \uc774\uc0c1\uc0ac\ub840 \ub370\uc774\ud130 \uc218\uc9d1 \ubc0f \uacbd\ud5a5 \ubd84\uc11d<br \/>\n&#8211; \uc7a5\uae30 \uc548\uc804\uc131 \ucd94\uc801\uc870\uc0ac \ubc0f \uc9c0\uc5f0 \uc774\uc0c1\uc0ac\ub840 \ubaa8\ub2c8\ud130\ub9c1<br \/>\n&#8211; \uc81c\ud488 \ud488\uc9c8 \ubd88\ub9cc \ubc0f \uae30\uae30 \uacb0\ud568 \ubcf4\uace0<\/li>\n<li><strong>Post-Market Clinical Studies<\/strong><br \/>\n&#8211; \uc758\ub8cc\uae30\uae30 \uc2dc\ud310 \ud6c4 \uc784\uc0c1\ucd94\uc801\uc870\uc0ac(PMCF) \uc2dc\ud5d8<br \/>\n&#8211; \ube44\uc911\uc7ac\uc801 \uc5f0\uad6c(NIS) \ubc0f \uad00\ucc30\uc801 \uc548\uc804\uc131 \uc5f0\uad6c<br \/>\n&#8211; \uaddc\uc81c \uc774\ud589\uc744 \uc704\ud55c \ud5c8\uac00 \ud6c4 \uc548\uc804\uc131 \uc5f0\uad6c(PASS)<br \/>\n&#8211; \ube44\uad50 \uc548\uc804\uc131 \ud3c9\uac00 \ubc0f \uc720\uc775\uc131-\uc704\ud574\uc131 \ud3c9\uac00<\/li>\n<li><strong>Registry Development &amp; Management<\/strong><br \/>\n&#8211; \ud658\uc790 \ub808\uc9c0\uc2a4\ud2b8\ub9ac \uc124\uacc4, \uad6c\ucd95 \ubc0f \uc7a5\uae30 \uc6b4\uc601<br \/>\n&#8211; \uc9c8\ud658\ubcc4\u00b7\uc81c\ud488\ubcc4 \ub808\uc9c0\uc2a4\ud2b8\ub9ac \uc804\ub7b5 \uc218\ub9bd<br \/>\n&#8211; \uad6d\ub0b4\uc678 \ub2e4\uae30\uad00 \ub808\uc9c0\uc2a4\ud2b8\ub9ac \uc870\uc815 \ubc0f \uc6b4\uc601<br \/>\n&#8211; \ub808\uc9c0\uc2a4\ud2b8\ub9ac \ub370\uc774\ud130\uc640 \uaddc\uc81c\uae30\uad00 \ubcf4\uace0 \uc694\uac74 \ud1b5\ud569<\/li>\n<li><strong>Regulatory Compliance &amp; Reporting<\/strong><br \/>\n&#8211; \uc2dc\ud310 \ud6c4 \uac10\uc2dc \ubcf4\uace0\uc11c \uc791\uc131 \ubc0f \uc81c\ucd9c<br \/>\n&#8211; \uc815\uae30\uc801 \uc548\uc804\uc131 \ucd5c\uc2e0\ubcf4\uace0\uc11c(PSUR) \uc791\uc131 \ubc0f \uc9d1\ud569\uc801 \ub370\uc774\ud130 \ubd84\uc11d<br \/>\n&#8211; \uaddc\uc81c\uae30\uad00 \uc2e4\uc0ac \ub300\ube44 \ubc0f \ubb38\uc11c\ud654 \uc9c0\uc6d0<br \/>\n&#8211; \ud5c8\uac00 \ud6c4 \uc870\uac74\ubd80 \uc774\ud589 \ubc0f \ub9c8\uc77c\uc2a4\ud1a4 \uad00\ub9ac<\/li>\n<\/ul>\n <\/div>[\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row][vc_row type=&#8221;full_width_background&#8221; full_screen_row_position=&#8221;middle&#8221; column_margin=&#8221;default&#8221; column_direction=&#8221;default&#8221; column_direction_tablet=&#8221;default&#8221; column_direction_phone=&#8221;default&#8221; bg_color=&#8221;#ffffff&#8221; scene_position=&#8221;center&#8221; bottom_padding=&#8221;5%&#8221; left_padding_desktop=&#8221;5%&#8221; constrain_group_2=&#8221;yes&#8221; right_padding_desktop=&#8221;5%&#8221; top_padding_tablet=&#8221;8%&#8221; constrain_group_3=&#8221;yes&#8221; bottom_padding_tablet=&#8221;8%&#8221; left_padding_phone=&#8221;0&#8243; constrain_group_6=&#8221;yes&#8221; right_padding_phone=&#8221;0&#8243; text_color=&#8221;dark&#8221; text_align=&#8221;left&#8221; row_border_radius=&#8221;none&#8221; row_border_radius_applies=&#8221;bg&#8221; overflow=&#8221;visible&#8221; id=&#8221;ClinicalPerformance&#8221; overlay_strength=&#8221;0.3&#8243; gradient_direction=&#8221;left_to_right&#8221; shape_divider_position=&#8221;bottom&#8221; bg_image_animation=&#8221;none&#8221; shape_type=&#8221;&#8221; gradient_type=&#8221;default&#8221;][vc_column column_padding=&#8221;no-extra-padding&#8221; column_padding_tablet=&#8221;inherit&#8221; column_padding_phone=&#8221;inherit&#8221; column_padding_position=&#8221;all&#8221; column_element_direction_desktop=&#8221;default&#8221; column_element_spacing=&#8221;default&#8221; desktop_text_alignment=&#8221;default&#8221; tablet_text_alignment=&#8221;default&#8221; phone_text_alignment=&#8221;default&#8221; background_color_opacity=&#8221;1&#8243; background_hover_color_opacity=&#8221;1&#8243; column_backdrop_filter=&#8221;none&#8221; column_shadow=&#8221;none&#8221; column_border_radius=&#8221;none&#8221; column_link_target=&#8221;_self&#8221; column_position=&#8221;default&#8221; gradient_direction=&#8221;left_to_right&#8221; overlay_strength=&#8221;0.3&#8243; width=&#8221;1\/1&#8243; tablet_width_inherit=&#8221;default&#8221; animation_type=&#8221;default&#8221; bg_image_animation=&#8221;none&#8221; border_type=&#8221;simple&#8221; column_border_width=&#8221;none&#8221; column_border_style=&#8221;solid&#8221;][vc_row_inner equal_height=&#8221;yes&#8221; content_placement=&#8221;middle&#8221; column_margin=&#8221;60px&#8221; column_direction=&#8221;default&#8221; column_direction_tablet=&#8221;column_reverse&#8221; column_direction_phone=&#8221;column_reverse&#8221; text_align=&#8221;left&#8221; row_position=&#8221;default&#8221; row_position_tablet=&#8221;inherit&#8221; row_position_phone=&#8221;inherit&#8221; overflow=&#8221;visible&#8221; pointer_events=&#8221;all&#8221;][vc_column_inner column_padding=&#8221;padding-4-percent&#8221; column_padding_tablet=&#8221;inherit&#8221; column_padding_phone=&#8221;no-extra-padding&#8221; column_padding_position=&#8221;all&#8221; top_margin=&#8221;6%&#8221; top_margin_tablet=&#8221;0&#8243; top_margin_phone=&#8221;4%&#8221; column_element_direction_desktop=&#8221;default&#8221; column_element_spacing=&#8221;default&#8221; desktop_text_alignment=&#8221;default&#8221; tablet_text_alignment=&#8221;default&#8221; phone_text_alignment=&#8221;default&#8221; background_color_opacity=&#8221;1&#8243; background_hover_color_opacity=&#8221;1&#8243; column_backdrop_filter=&#8221;none&#8221; column_shadow=&#8221;none&#8221; column_border_radius=&#8221;none&#8221; column_link_target=&#8221;_self&#8221; overflow=&#8221;visible&#8221; gradient_direction=&#8221;radial&#8221; overlay_strength=&#8221;0.3&#8243; width=&#8221;3\/5&#8243; tablet_width_inherit=&#8221;default&#8221; animation_type=&#8221;default&#8221; bg_image_animation=&#8221;none&#8221; parallax_bg=&#8221;true&#8221; parallax_bg_speed=&#8221;very_subtle&#8221; border_type=&#8221;simple&#8221; column_border_width=&#8221;none&#8221; column_border_style=&#8221;solid&#8221;][split_line_heading animation_type=&#8221;line-reveal-by-space&#8221; font_style=&#8221;h2&#8243; line_reveal_by_space_text_effect=&#8221;default&#8221; stagger_animation=&#8221;true&#8221; content_alignment=&#8221;default&#8221; mobile_content_alignment=&#8221;inherit&#8221; link_target=&#8221;_self&#8221; text_content=&#8221;Clinical Performance &amp; Evaluation&#8221; max_width=&#8221;500&#8243; text_direction=&#8221;default&#8221; font_line_height=&#8221;1.3&#8243; font_size=&#8221;40&#8243; font_size_phone=&#8221;28&#8243;][\/split_line_heading][split_line_heading animation_type=&#8221;line-reveal-by-space&#8221; font_style=&#8221;h5&#8243; line_reveal_by_space_text_effect=&#8221;default&#8221; stagger_animation=&#8221;true&#8221; content_alignment=&#8221;default&#8221; mobile_content_alignment=&#8221;inherit&#8221; link_target=&#8221;_self&#8221; text_content=&#8221;\ud5c8\uac00\u00b7\uc778\uc99d\u00b7\ubcf4\ud5d8 \ub4f1\uc7ac\ub97c \uc704\ud55c \uc2e4\uc0ac\uc6a9 \uae30\ubc18 \uc2e4\uc99d \uc911\uc2ec \uc5f0\uad6c&#8221; max_width=&#8221;550&#8243; font_line_height=&#8221;1.3&#8243; text_direction=&#8221;default&#8221; font_size=&#8221;24&#8243; font_size_phone=&#8221;22&#8243;][\/split_line_heading]<div class=\"nectar-fancy-ul font_size_desktop_18px font_line_height_1-5\" data-list-icon=\"icon-salient-check\" data-animation=\"false\" data-animation-delay=\"0\" data-color=\"extra-color-2\" data-spacing=\"default\" data-alignment=\"left\"> <strong>Core Services<\/strong><\/p>\n<ul>\n<li><strong>Real-World Evidence (RWE) Generation<\/strong><br \/>\n&#8211; \uc720\ud6a8\uc131 \ubd84\uc11d\uc744 \uc704\ud55c \uc2e4\uc0ac\uc6a9\ub370\uc774\ud130(RWD) \uae30\ubc18 \uc784\uc0c1\uc801 \uc131\ub2a5 \uc5f0\uad6c<br \/>\n&#8211; \ube44\uad50 \ud6a8\uacfc \uc5f0\uad6c \ubc0f \uce58\ub8cc \ud328\ud134 \ubd84\uc11d<br \/>\n&#8211; \uc758\ub8cc\uae30\uc220\ud3c9\uac00(HTA) \uadfc\uac70 \uc790\ub8cc \uc900\ube44<br \/>\n&#8211; \uc2dc\ud310 \ud6c4 \uc131\ub2a5 \ubaa8\ub2c8\ud130\ub9c1 \ubc0f \uc9c0\uc18d\uc801 \uc720\uc775\uc131-\uc704\ud574\uc131 \ud3c9\uac00<\/li>\n<li><strong>User Experience &amp; Usability<\/strong><br \/>\n&#8211; \uc758\ub8cc\uae30\uae30 \ubc0f \ub514\uc9c0\ud138 \ud5ec\uc2a4 \ub300\uc0c1 \uc778\uc801\uc694\uc778(Human Factors) \ubc0f \uc0ac\uc6a9\uc801\ud569\uc131 \ud3c9\uac00<br \/>\n&#8211; \uc0ac\uc6a9\uc790 \uc778\ud130\ub799\uc158 \uc5f0\uad6c \ubc0f \uc778\ud130\ud398\uc774\uc2a4 \ucd5c\uc801\ud654<br \/>\n&#8211; \ub514\uc9c0\ud138 \uae30\uae30 \uc0ac\uc6a9\uc790 \ud589\ub3d9 \ubd84\uc11d \ubc0f \ucc38\uc5ec \uc9c0\ud45c \ud3c9\uac00<br \/>\n&#8211; \ud658\uc790\ubcf4\uace0\uacb0\uacfc(PRO) \ubc0f \uc0b6\uc758 \uc9c8 \ud3c9\uac00<\/li>\n<li><strong>Regulatory Support<br \/>\n<\/strong>&#8211; \uc81c\ud488 \uc778\uc99d \ubc0f \uc2dc\uc7a5 \ud655\ub300\ub97c \uc704\ud55c \uc784\uc0c1\uc801 \uadfc\uac70 \ud328\ud0a4\uc9c0 \uad6c\uc131<br \/>\n&#8211; \uc2e4\uc0ac\uc6a9\uc99d\uac70(RWE) \ud504\ub85c\uadf8\ub7a8\uacfc \uc2dc\ud310 \ud6c4 \uc784\uc0c1\ucd94\uc801\uc870\uc0ac(PMCF) \ud1b5\ud569<br \/>\n&#8211; \ub77c\ubca8 \ud655\uc7a5 \ubc0f \uc801\uc751\uc99d \ucd94\uac00\ub97c \uc704\ud55c \uadfc\uac70 \uc804\ub7b5 \uc218\ub9bd<\/li>\n<li><strong>Market Differentiation Studies<\/strong><br \/>\n&#8211; \ube0c\ub79c\ub4dc \ud3ec\uc9c0\uc154\ub2dd \ubc0f \ub9c8\ucf00\ud305 \ud074\ub808\uc784\uc744 \uc704\ud55c \uc784\uc0c1\uc2dc\ud5d8 \uc124\uacc4<br \/>\n&#8211; \uc81c\ud488 \uac04 \ube44\uad50 \uc131\ub2a5 \ud3c9\uac00<br \/>\n&#8211; \ub3c5\ub9bd\uc801 \ud3c9\uac00\ub97c \ud1b5\ud55c \uc2dc\uc220 \uc804\ud6c4 \uacb0\uacfc \ubb38\uc11c\ud654<br \/>\n&#8211; \uadfc\uac70 \uae30\ubc18 \ud3c9\uac00\ubcc0\uc218\ub85c\ubd80\ud130\uc758 \uc784\uc0c1 \uba54\uc2dc\uc9c0 \ub3c4\ucd9c<\/li>\n<\/ul>\n <\/div>[\/vc_column_inner][vc_column_inner column_padding=&#8221;padding-4-percent&#8221; 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