{"id":8266,"date":"2024-07-03T11:33:29","date_gmt":"2024-07-03T11:33:29","guid":{"rendered":"https:\/\/lentisco.es\/regulatory-and-access\/"},"modified":"2025-03-17T10:18:44","modified_gmt":"2025-03-17T10:18:44","slug":"regulatory-and-access","status":"publish","type":"page","link":"https:\/\/lentisco.es\/en\/regulatory-and-access\/","title":{"rendered":"Regulatory and Access"},"content":{"rendered":"

[et_pb_section fb_built=”1″ _builder_version=”4.24.3″ use_background_color_gradient=”on” background_color_gradient_stops=”rgba(104,0,0,0.3) 15%|rgba(105,3,3,0.3) 100%” background_color_gradient_overlays_image=”on” background_image=”https:\/\/lentisco.es\/wp-content\/uploads\/2024\/04\/atlas3.jpg” custom_padding=”0|0px|0|0px|false|false” global_colors_info=”{}”][et_pb_row _builder_version=”4.24.3″ _module_preset=”default” height=”500px” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.24.3″ _module_preset=”default” global_colors_info=”{}”][et_pb_text _builder_version=”4.24.3″ _module_preset=”default” header_font_size=”40px” custom_padding=”280px||||false|false” custom_padding_tablet=”280px||||false|false” custom_padding_phone=”250px||||false|false” custom_padding_last_edited=”on|phone” hover_enabled=”0″ header_font_size_tablet=”35px” header_font_size_phone=”30px” header_font_size_last_edited=”on|phone” text_text_shadow_style=”preset3″ text_text_shadow_blur_strength=”1em” text_text_shadow_color=”#000000″ global_colors_info=”{}” sticky_enabled=”0″]<\/p>\n

Regulatory and access to the HEALTH MARKET<\/strong><\/span><\/h1>\n

[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ _builder_version=”4.24.3″ _module_preset=”default” custom_padding=”0px|||||” global_colors_info=”{}”][et_pb_row column_structure=”1_2,1_2″ _builder_version=”4.24.3″ _module_preset=”default” custom_padding=”60px||0px|||” global_colors_info=”{}”][et_pb_column type=”1_2″ _builder_version=”4.24.3″ _module_preset=”default” global_colors_info=”{}”][et_pb_text _builder_version=”4.24.3″ _module_preset=”default” global_colors_info=”{}”]<\/p>\n

Regulatory and Market Access for Medical Devices in Spain<\/b><\/h3>\n

<\/b><\/p>\n

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Lentisco understands the particularities of the process for medical devices to reach the Spanish market. We know that these products, ranging from medical devices to diagnostic equipment, require a specific approach to comply with regulations and achieve successful commercialization. Our team of experts provides comprehensive support, covering all phases of the regulatory and market access process. <\/span><\/p>\n

 <\/p>\n

[\/et_pb_text][\/et_pb_column][et_pb_column type=”1_2″ _builder_version=”4.24.3″ _module_preset=”default” global_colors_info=”{}”][et_pb_text _builder_version=”4.24.3″ _module_preset=”default” background_image=”https:\/\/lentisco.es\/wp-content\/uploads\/2024\/04\/fungible5.jpg” min_height=”300px” height=”300px” border_radii=”on|20px|20px|20px|20px” global_colors_info=”{}”][\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ _builder_version=”4.24.3″ _module_preset=”default” background_color=”#690303″ global_colors_info=”{}”][et_pb_row column_structure=”3_5,2_5″ _builder_version=”4.16″ global_colors_info=”{}”][et_pb_column type=”3_5″ _builder_version=”4.16″ custom_padding=”|||” global_colors_info=”{}” custom_padding__hover=”|||”][et_pb_text _builder_version=”4.24.3″ global_colors_info=”{}”]<\/p>\n

Regulatory Services for Medical Devices<\/b><\/span><\/h3>\n

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Medical devices must comply with regulations that guarantee their safety and efficacy before being marketed in Spain. In Lentisco we offer: <\/span><\/p>\n

[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=”4.24.3″ _module_preset=”default” custom_margin=”30px||30px||true|false” custom_padding=”5px||||false|false” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.24.3″ _module_preset=”default” global_colors_info=”{}”][ba_image_carousel use_pagi=”on” slide_spacing=”25px” is_infinite=”off” css_transition=”linear” is_swipe=”off” wait_for_animate=”off” custom_cursor=”on” carousel_spacing_top=”0px” carousel_spacing_bottom=”0px” nav_height=”30px” nav_width=”30px” nav_icon_size=”22px” nav_color=”#690303″ nav_bg=”#FFFFFF” nav_border_width=”1px” nav_border_color=”#FFFFFF” pagi_bg=”#5B6770″ pagi_radius=”off|10px|10px|10px|10px” pagi_bg_active=”#FFFFFF” slide_count_tablet=”1″ slide_count_phone=”1″ slide_count_last_edited=”on|desktop” _builder_version=”4.24.3″ _module_preset=”default” custom_margin=”||||false|false” custom_css_free_form=”.dtq-image-subtitle {|| text-transform: none;||text-align: justify;|| margin-top: 20px;||}||.dtq-image-carousel-item figure img {|| width: 100%;|| border-radius:20px;|| height:180px;||}” global_colors_info=”{}” nav_bg__hover_enabled=”on|hover” nav_bg__hover=”RGBA(255,255,255,0)” nav_color__hover_enabled=”on|hover” nav_color__hover=”#FFFFFF” nav_border_color__hover_enabled=”on|desktop” nav_border_color__hover=”#FFFFFF”][ba_image_carousel_child photo=”https:\/\/lentisco.es\/wp-content\/uploads\/2024\/04\/fungible8.jpg” title=”Integrated bid management” sub_title=”We handle all aspects of the bidding process, from the identification of opportunities to the submission of bids. This encompasses the preparation of documents, compliance with legal and technical requirements, and the formulation of bidding strategies. ” _builder_version=”4.24.3″ _module_preset=”default” title_level=”h3″ title_font=”|700|||||||” title_text_color=”#FFFFFF” subtitle_level=”h5″ subtitle_font=”||||||||” subtitle_text_color=”#FFFFFF” subtitle_letter_spacing=”0px” subtitle_line_height=”1.4em” global_colors_info=”{}”][\/ba_image_carousel_child][ba_image_carousel_child photo=”https:\/\/lentisco.es\/wp-content\/uploads\/2024\/04\/fungible2.jpg” title=”Regulatory strategy for medical devices” sub_title=”We develop strategies adapted to the specific regulations of the Spanish Agency of Medicines and Health Products (AEMPS) and European regulations, facilitating a clear and effective approval process.” _builder_version=”4.24.3″ _module_preset=”default” title_level=”h3″ title_font=”|700|||||||” title_text_color=”#FFFFFF” subtitle_level=”h5″ subtitle_font=”||||||||” subtitle_text_color=”#FFFFFF” subtitle_letter_spacing=”0px” subtitle_line_height=”1.4em” global_colors_info=”{}”][\/ba_image_carousel_child][ba_image_carousel_child photo=”https:\/\/lentisco.es\/wp-content\/uploads\/2024\/04\/fungible3.jpg” title=”CE marking and conformity assessment” sub_title=”We advise on the CE marking process, which includes the conformity assessment necessary to demonstrate that products comply with the essential safety and performance requirements established by European legislation.” _builder_version=”4.24.3″ _module_preset=”default” title_level=”h3″ title_font=”|700|||||||” title_text_color=”#FFFFFF” subtitle_level=”h5″ subtitle_font=”||||||||” subtitle_text_color=”#FFFFFF” subtitle_letter_spacing=”0px” subtitle_line_height=”1.4em” global_colors_info=”{}”][\/ba_image_carousel_child][ba_image_carousel_child photo=”https:\/\/lentisco.es\/wp-content\/uploads\/2024\/04\/fungible4.jpg” title=”Registrations and notifications at the AEMPS” sub_title=”We manage the notification and registration of medical devices with the AEMPS, ensuring that all legal requirements are covered, from product classification to the submission of technical documentation.” _builder_version=”4.24.3″ _module_preset=”default” title_level=”h3″ title_font=”|700|||||||” title_text_color=”#FFFFFF” subtitle_level=”h5″ subtitle_font=”||||||||” subtitle_text_color=”#FFFFFF” subtitle_letter_spacing=”0px” subtitle_line_height=”1.4em” global_colors_info=”{}”][\/ba_image_carousel_child][ba_image_carousel_child photo=”https:\/\/lentisco.es\/wp-content\/uploads\/2024\/04\/6727.jpg” title=”Post-Marketing Support” sub_title=”We provide continuous monitoring to manage incidents, documentation updates and maintain regulatory compliance throughout the product lifecycle.” _builder_version=”4.24.3″ _module_preset=”default” title_level=”h3″ title_font=”|700|||||||” title_text_color=”#FFFFFF” subtitle_level=”h5″ subtitle_font=”||||||||” subtitle_text_color=”#FFFFFF” subtitle_letter_spacing=”0px” subtitle_line_height=”1.4em” global_colors_info=”{}”][\/ba_image_carousel_child][\/ba_image_carousel][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ _builder_version=”4.24.3″ _module_preset=”default” custom_padding=”||1px|||” global_colors_info=”{}”][et_pb_row column_structure=”1_2,1_2″ _builder_version=”4.24.3″ _module_preset=”default” min_height=”406px” custom_padding=”0px||0px|||” global_colors_info=”{}”][et_pb_column type=”1_2″ _builder_version=”4.24.3″ _module_preset=”default” global_colors_info=”{}”][et_pb_text _builder_version=”4.24.3″ _module_preset=”default” background_image=”https:\/\/lentisco.es\/wp-content\/uploads\/2024\/04\/fungible6.jpg” max_width=”250%” min_height=”400px” height=”400px” custom_margin=”||-208px|||” border_radii=”on|20px|20px|20px|20px” global_colors_info=”{}”][\/et_pb_text][\/et_pb_column][et_pb_column type=”1_2″ _builder_version=”4.24.3″ _module_preset=”default” global_colors_info=”{}”][et_pb_text _builder_version=”4.24.3″ _module_preset=”default” header_2_line_height=”1.2em” custom_margin=”1px|||||” global_colors_info=”{}”]<\/p>\n

Access to the medical devices market<\/b><\/h3>\n

[\/et_pb_text][et_pb_text _builder_version=”4.24.3″ _module_preset=”default” global_colors_info=”{}”]<\/p>\n

Successful access to the medical device market depends not only on regulatory compliance, but also on an effective commercialization strategy. At Lentisco, we provide: <\/span><\/p>\n

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<\/p>\n

Market analysis for medical devices<\/b><\/h4>\n

We conduct specific studies of the medical devices market to identify opportunities for entry and expansion, considering the characteristics of the sector and demand.<\/span><\/p>\n

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<\/p>\n

Pricing and distribution channel strategies<\/b><\/h4>\n

We advise on pricing and on the definition of distribution strategies that maximize the penetration of the product in the Spanish market, adapted to the particularities of medical devices.<\/span><\/p>\n

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<\/p>\n

Launch and promotion<\/b><\/h4>\n

We develop launch plans and marketing strategies aimed at ensuring product visibility and adoption in the market, including dialogue with hospitals, clinics and other key points.<\/span><\/p>\n

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<\/p>\n

Collaboration with healthcare institutions and professionals<\/b><\/h4>\n

We facilitate contact with healthcare institutions and professionals in the sector to guarantee effective access based on the trust of end users.<\/span><\/p>\n

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Regulatory services for drugs<\/b><\/h3>\n

The marketing of medicines in Spain is subject to a rigorous regulatory framework that guarantees the safety, efficacy and quality of pharmaceutical products. At Lentisco, we offer a comprehensive service that accompanies companies at every stage of the process, from regulatory approval to market access, ensuring that drugs reach patients safely and effectively. <\/span><\/p>\n

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Regulatory services for drugs<\/b><\/span><\/h3>\n

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The drug approval process in Spain is complex and requires strict compliance with current regulations. Our services include: <\/span><\/p>\n

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Access to the drug market<\/b><\/h3>\n

 <\/p>\n

To ensure that medicines effectively reach patients in Spain, a solid market access strategy is necessary. At Lentisco, we provide: <\/span><\/p>\n

[\/et_pb_text][et_pb_sidebar _builder_version=”4.24.3″ _module_preset=”default” global_colors_info=”{}”][\/et_pb_sidebar][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=”1_2,1_2″ _builder_version=”4.24.3″ _module_preset=”default” min_height=”523px” global_colors_info=”{}”][et_pb_column type=”1_2″ _builder_version=”4.24.3″ _module_preset=”default” global_colors_info=”{}”][et_pb_text _builder_version=”4.24.3″ _module_preset=”default” global_colors_info=”{}”]<\/p>\n

    \n
  • Market analysis for pharmaceuticals:<\/b> we conduct a detailed analysis of the pharmaceutical market to identify access opportunities and optimize the entry strategy.<\/span><\/li>\n
  • Pricing and reimbursement strategies:<\/b> We advise on pricing and negotiations with health authorities to ensure reimbursement and maximize drug accessibility.<\/span><\/li>\n
  • Launch planning:<\/b> we design launch plans that ensure successful introduction and sustained market penetration, aligned with commercial and regulatory objectives.<\/span><\/li>\n
  • Relations with health authorities:<\/b> we facilitate contact and negotiations with relevant entities, including the Ministry of Health and the Autonomous Communities, to ensure efficient market access.<\/span><\/li>\n<\/ul>\n

    [\/et_pb_text][\/et_pb_column][et_pb_column type=”1_2″ _builder_version=”4.24.3″ _module_preset=”default” global_colors_info=”{}”][et_pb_image src=”https:\/\/lentisco.es\/wp-content\/uploads\/2024\/07\/caracteristicas-del-sector-farmaceutico.png” alt=”Characteristics of the pharmaceutical sector” title_text=”characteristics-of-the-pharmaceuticals-sector” _builder_version=”4.24.3″ _module_preset=”default” border_radii=”on|20px|20px|20px|20px” global_colors_info=”{}”][\/et_pb_image][\/et_pb_column][\/et_pb_row][\/et_pb_section]<\/p>\n","protected":false},"excerpt":{"rendered":"

    Regulatory and access to the HEALTH MARKETRegulatory and Market Access for Medical Devices in Spain Lentisco understands the particularities of the process for medical devices to reach the Spanish market. We know that these products, ranging from medical devices to diagnostic equipment, require a specific approach to comply with regulations and achieve successful commercialization. Our […]<\/p>\n","protected":false},"author":6,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_et_pb_use_builder":"on","_et_pb_old_content":"","_et_gb_content_width":"","_joinchat":[],"footnotes":""},"class_list":["post-8266","page","type-page","status-publish","hentry"],"yoast_head":"\nRegulatory and Access - Lentisco<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/lentisco.es\/en\/regulatory-and-access\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Regulatory and Access - Lentisco\" \/>\n<meta property=\"og:description\" content=\"Regulatory and access to the HEALTH MARKETRegulatory and Market Access for Medical Devices in Spain Lentisco understands the particularities of the process for medical devices to reach the Spanish market. We know that these products, ranging from medical devices to diagnostic equipment, require a specific approach to comply with regulations and achieve successful commercialization. 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