RAPS – Regulatory Readiness & Resources 2024

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2024 RAPS & Celegence Regulatory & Readiness Survey

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Get instant access to the survey report that regulatory professionals are talking about: the 2024 RAPS & Celegence Regulatory & Readiness Survey.

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698 regulatory professionals weigh in on the direction for the medical device and pharmaceutical industries. See the interesting findings – download it now.

[/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=”30px” 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=””]Celegence partnered with RAPS, Regulatory Affairs Professionals Society, on a survey to Regulatory Affairs professionals. We looked at topics around current challenges, investments, technology, processes, staffing, skillsets and future outlook to better understand industry direction.

Given the strong response rate and interest, we were able to compile the results into two distinct segments:

1. Pharmaceuticals (includes Pharma and Combination Products)
2. Medical Devices

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center” linear_angle=”180″ background_image_medium=”” background_image_small=”” background_image=”” background_image_id_medium=”” background_image_id_small=”” background_image_id=”” lazy_load=”none” skip_lazy_load=”” background_position_medium=”” background_position_small=”” background_position=”left top” background_repeat_medium=”” background_repeat_small=”” background_repeat=”no-repeat” background_size_medium=”” background_size_small=”” background_size=”” background_custom_size=”” background_custom_size_medium=”” background_custom_size_small=”” background_blend_mode_medium=”” background_blend_mode_small=”” background_blend_mode=”none” background_slider_images=”” background_slider_position=”” background_slider_skip_lazy_loading=”no” background_slider_loop=”yes” background_slider_pause_on_hover=”no” background_slider_slideshow_speed=”5000″ background_slider_animation=”fade” background_slider_direction=”up” background_slider_animation_speed=”800″ background_slider_blend_mode=”” render_logics=”” sticky=”off” sticky_devices=”small-visibility,medium-visibility,large-visibility” sticky_offset=”” absolute=”off” absolute_top=”” absolute_right=”” absolute_bottom=”” absolute_left=”” filter_type=”regular” filter_hover_element=”self” filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ transform_type=”regular” 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=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=”” last=”false” border_position=”all” first=”true”][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=”Poppins” fusion_font_variant_text_font=”500″ font_size=”20px” line_height=”” letter_spacing=”” text_transform=”” text_color=”var(–awb-color1)” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=”” logics=””]Pharmaceutical Industry Regulatory Readiness & Resources
2024 Survey Report[/fusion_text][/fusion_builder_column_inner][fusion_builder_column_inner type=”1_2″ layout=”1_2″ 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″ spacing_left_medium=”” spacing_right_medium=”” spacing_left_small=”” spacing_right_small=”” spacing_left=”” spacing_right=”” margin_top_medium=”” margin_bottom_medium=”” margin_top_small=”” margin_bottom_small=”” margin_top=”” margin_bottom=”” padding_top_medium=”” padding_right_medium=”” padding_bottom_medium=”” padding_left_medium=”” padding_top_small=”” 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text_color=”var(–awb-color1)” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=”” logics=””]Medical Devices Industry Regulatory Readiness & Resources
2024 Survey Report[/fusion_text][/fusion_builder_column_inner][/fusion_builder_row_inner][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=”30px” 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=””]

With two distinct reports available, one focused on the Pharmaceutical Industry and one on the Medical Device Industry these reports will allow you to gain an understanding of what issues and challenges companies in the Life Sciences Industry face in 2024.

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There were a few questions specific to each segment, and several questions were the same for comparison. Here are a few takeaways – 

[/fusion_text][fusion_checklist type=”icons” icon=”fa-check fas” iconcolor=”var(–awb-color6)” hue=”” saturation=”” lightness=”” alpha=”” circle=”” circlecolor=”rgba(255,255,255,0)” textcolor=”” size=”16px” item_padding_top=”” item_padding_right=”” item_padding_bottom=”” item_padding_left=”” divider=”” divider_color=”” odd_row_bgcolor=”” even_row_bgcolor=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” parent_dynamic_content=””][fusion_li_item icon=”” iconcolor=”” hue=”” saturation=”” lightness=”” alpha=”” circlecolor=””]Top two Regulatory challenges for both pharma and medical devices:

1. Time/bandwidth
2. Cost/managing budget

[/fusion_li_item][fusion_li_item icon=”” iconcolor=”” hue=”” saturation=”” lightness=”” alpha=”” circlecolor=””]

In fact, 77% in Medical Devices and 55% in Pharma said they have insufficient resources to complete all of 2024 priorities

[/fusion_li_item][fusion_li_item icon=”” iconcolor=”” hue=”” saturation=”” lightness=”” alpha=”” circlecolor=””]

Pharma:

• 81% see the benefit of eCTD v4.0 and over two-thirds are planning submissions in eCTD v4.0 format; 60% are planning an assessment in v4.

[/fusion_li_item][fusion_li_item icon=”” iconcolor=”” hue=”” saturation=”” lightness=”” alpha=”” circlecolor=””]

Medical devices:

• 58% of Regulatory Affairs leaders will spend more on MDR/IVDR maintenance in 2024

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Thank you to all who contributed to the survey and had your say. We invite you to download the report and also engage in a conversation on the direction of regulatory affairs.

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