{"id":8314,"date":"2024-09-24T15:52:48","date_gmt":"2024-09-24T15:52:48","guid":{"rendered":"https:\/\/lentisco.es\/regulatory-affairs\/"},"modified":"2025-03-17T10:18:44","modified_gmt":"2025-03-17T10:18:44","slug":"regulatory-affairs","status":"publish","type":"page","link":"https:\/\/lentisco.es\/en\/regulatory-affairs\/","title":{"rendered":"Regulatory Affairs"},"content":{"rendered":"

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consultancy specialized in regulatory affairs<\/strong><\/span><\/h1>\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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    • Regulatory strategy for medicines:<\/b> we develop regulatory strategies that are aligned with the guidelines of the Spanish Agency for Medicines and Health Products (AEMPS) and European regulations, to facilitate marketing authorization.<\/span><\/li>\n
    • Pre and post-sale product management: <\/b>leaflet, technical data sheet, packaging, etc.<\/span><\/li>\n
    • Development of the regulatory dossier:<\/b> we advise on the preparation and submission of the dossier required for marketing authorization, ensuring that it meets the required scientific and technical standards.<\/span><\/li>\n
    • Registration and licensing of medicines:<\/b> we manage the registration of medicines with the AEMPS, including the obtaining of marketing licenses and the management of decentralized or centralized procedures.<\/span><\/li>\n
    • Post-Authorization and Surveillance:<\/b> we provide ongoing support for variation, renewal and pharmacovigilance management, ensuring regulatory compliance throughout the drug’s lifecycle.<\/span><\/li>\n
    • Management of educational and promotional materials.<\/b><\/li>\n
    • Drug safety management.<\/b><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n

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      consultancy specialized in regulatory affairsThe drug approval process in Spain is complex and requires strict compliance with current regulations. Our services include: Regulatory strategy for medicines: we develop regulatory strategies that are aligned with the guidelines of the Spanish Agency for Medicines and Health Products (AEMPS) and European regulations, to facilitate marketing authorization. Pre and […]<\/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-8314","page","type-page","status-publish","hentry"],"yoast_head":"\nRegulatory Affairs - 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-affairs\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Regulatory Affairs - Lentisco\" \/>\n<meta property=\"og:description\" content=\"consultancy specialized in regulatory affairsThe drug approval process in Spain is complex and requires strict compliance with current regulations. Our services include: Regulatory strategy for medicines: we develop regulatory strategies that are aligned with the guidelines of the Spanish Agency for Medicines and Health Products (AEMPS) and European regulations, to facilitate marketing authorization. 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