{"id":313,"date":"2022-09-02T15:44:51","date_gmt":"2022-09-02T15:44:51","guid":{"rendered":"https:\/?page_id=313"},"modified":"2025-09-08T12:09:41","modified_gmt":"2025-09-08T11:09:41","slug":"servicios-de-desarrollo-farmaceutico","status":"publish","type":"page","link":"https:\/\/pharmaceuticalinnovation.es\/es\/servicios-de-desarrollo-farmaceutico\/","title":{"rendered":"Servicios"},"content":{"rendered":"

[et_pb_section fb_built=”1″ custom_padding_last_edited=”on|tablet” admin_label=”Hero” _builder_version=”4.27.4″ background_enable_color=”off” use_background_color_gradient=”on” background_color_gradient_type=”circular” background_color_gradient_direction_radial=”bottom left” background_color_gradient_stops=”#9d3e82 0%|rgba(10,10,10,0) 100%” background_color_gradient_overlays_image=”on” background_color_gradient_start=”#af00a1″ background_color_gradient_end=”rgba(10,10,10,0)” background_image=”\/\/\/wp-content\/uploads\/2022\/09\/laboratory-gffa24413c_1920-1.jpg” background_enable_video_mp4=”off” height=”430px” custom_padding=”0px|0px|0px|0px|false|false” custom_padding_tablet=”50px||50px||true” custom_padding_phone=”|||” bottom_divider_style=”asymmetric2″ bottom_divider_color=”#FFFFFF” bottom_divider_height=”50px” bottom_divider_flip=”horizontal” bottom_divider_arrangement=”above_content” bottom_divider_height_tablet=”90px” bottom_divider_height_phone=”80px” locked=”off” collapsed=”on” global_colors_info=”{}”][et_pb_row _builder_version=”4.16″ custom_margin=”|-16px||347px||” custom_padding=”9px|||||” custom_width_px=”1280px” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.16″ background_color_gradient_direction=”90deg” custom_padding=”|||” global_colors_info=”{}” custom_padding__hover=”|||”][et_pb_text _builder_version=”4.27.4″ text_font=”Montserrat||||||||” text_text_color=”rgba(255,255,255,0.7)” text_font_size=”20px” text_line_height=”1.8em” header_font=”Montserrat|700|||||||” header_font_size=”44px” header_line_height=”1.4em” header_6_font=”Montserrat|600||on|||||” header_6_text_color=”rgba(255,255,255,0.7)” header_6_font_size=”16px” header_6_letter_spacing=”2px” header_6_line_height=”1.5em” background_layout=”dark” max_width=”985px” custom_margin=”69px||||false|false” hover_enabled=”0″ text_font_size_tablet=”” text_font_size_phone=”15px” text_font_size_last_edited=”on|phone” header_font_size_tablet=”” header_font_size_phone=”28px” header_font_size_last_edited=”on|phone” global_colors_info=”{}” sticky_enabled=”0″]<\/p>\n

Pharmaceutical Development, Regulatory Affairs, Quality Assurance and Pharmacovigilance Services<\/p>\n

Our Pharmaceutical Development Services <\/strong><\/span><\/h1>\n

We are proud to provide a wide range of high-quality services in the following areas:<\/span>[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ admin_label=”Servicio #1″ module_id=”new” _builder_version=”4.19.0″ _module_preset=”default” background_color=”#ffffff” locked=”off” collapsed=”on” global_colors_info=”{}”][et_pb_row _builder_version=”4.19.0″ _module_preset=”default” width_tablet=”” width_phone=”” width_last_edited=”on|desktop” max_width=”1200px” max_width_tablet=”1200px” max_width_phone=”1200px” max_width_last_edited=”on|desktop” custom_margin=”||||false|false” custom_padding=”||2px||false|false” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.16″ _module_preset=”default” custom_padding=”0px|0px|0px|0px|false|false” global_colors_info=”{}”][et_pb_divider color=”#cc00e2″ _builder_version=”4.16″ _module_preset=”default” custom_margin=”6px|||||” global_colors_info=”{}”][\/et_pb_divider][et_pb_text quote_border_color=”#8c1d6c” module_id=”new” _builder_version=”4.27.0″ text_font=”Montserrat||||||||” text_text_color=”#000000″ text_font_size=”16px” text_line_height=”1.8em” quote_font=”||||||||” header_font=”||||||||” header_2_font=”Montserrat||||||||” header_2_text_color=”#8c1d6c” header_2_font_size=”30px” header_2_line_height=”1.4em” header_6_font=”Montserrat|600||on|||||” header_6_text_color=”#088b8c” header_6_font_size=”16px” header_6_letter_spacing=”2px” header_6_line_height=”1.5em” background_layout=”dark” max_width=”600px” custom_margin=”-7px||-30px||false|false” custom_padding=”||0px||false|false” header_2_font_size_tablet=”” header_2_font_size_phone=”24px” header_2_font_size_last_edited=”on|phone” locked=”off” global_colors_info=”{}”]<\/p>\n

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New Product Development<\/strong><\/span><\/span><\/h2>\n<\/blockquote>\n

[\/et_pb_text][et_pb_text _builder_version=”4.19.0″ _module_preset=”default” custom_margin=”|||30px|false|false” custom_margin_tablet=”|||30px|false|false” custom_margin_phone=”50px|||0px|false|false” custom_margin_last_edited=”on|phone” custom_padding_tablet=”” custom_padding_phone=”” custom_padding_last_edited=”on|phone” global_colors_info=”{}”]<\/p>\n

Innovation, design and\/or development of new products are fundamental activities in order to face the dynamic pharma market.
Pharmaceutical Innovation Services, S.L. has a multidisciplinary team that will guide you throughout the whole product development and manufacturing process. In this way, we will help you obtain a suitable product, in terms of stability, application and industrial manufacturing characteristics.<\/p>\n

[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=”1_3,1_3,1_3″ _builder_version=”4.27.4″ _module_preset=”default” background_enable_video_mp4=”off” width_tablet=”” width_phone=”” width_last_edited=”on|desktop” max_width=”1200px” max_width_tablet=”1200px” max_width_phone=”1200px” max_width_last_edited=”on|desktop” global_colors_info=”{}”][et_pb_column type=”1_3″ _builder_version=”4.19.0″ _module_preset=”default” custom_padding=”|||30px|false|false” custom_padding_tablet=”|||30px|false|false” custom_padding_phone=”|||30px|false|false” custom_padding_last_edited=”on|desktop” global_colors_info=”{}”][et_pb_text _builder_version=”4.19.0″ _module_preset=”default” custom_margin=”||||false|false” custom_margin_tablet=”||||false|false” custom_margin_phone=”|||-30px|false|false” custom_margin_last_edited=”on|phone” custom_padding_tablet=”” custom_padding_phone=”” custom_padding_last_edited=”on|phone” global_colors_info=”{}”]<\/p>\n

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  • Selection and qualification of suppliers (API, CDMO, CRO). <\/span><\/li>\n
  • GMP and GDP audits to suppliers<\/span><\/li>\n
  • Search for funding and partnership.<\/span><\/li>\n
  • Definition of the best regulatory strategy for the new product to access the market.<\/span><\/li>\n
  • Support in the formulation and development and validation of analytical methods.<\/span><\/li>\n
  • R&D Strategy, technical feasibility analysis and risk assessment of the project.<\/span><\/span><\/li>\n<\/ul>\n

    [\/et_pb_text][\/et_pb_column][et_pb_column type=”1_3″ _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][et_pb_text _builder_version=”4.19.0″ _module_preset=”default” custom_margin=”||||false|false” custom_margin_tablet=”||||false|false” custom_margin_phone=”-40px||||false|false” custom_margin_last_edited=”on|phone” custom_padding_tablet=”” custom_padding_phone=”” custom_padding_last_edited=”on|phone” global_colors_info=”{}”]<\/p>\n

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    • Conducting manufacturing supplier audits and DMF evaluation.<\/li>\n
    • Definition of project strategy and management of activities and timelines, with a focus on meeting customer-specific needs to deliver the highest quality product on time.<\/li>\n
    • Galenic and analytical development guidance and support during development phase including review of technical protocols and reports.<\/li>\n<\/ul>\n

      [\/et_pb_text][\/et_pb_column][et_pb_column type=”1_3″ _builder_version=”4.27.4″ _module_preset=”default” background_video_mp4=”https:\/\/pharmaceuticalinnovation.es\/wp-content\/uploads\/2022\/09\/NEW-PRODUCTS-DEVELOPMENT-AREA-1.mov” custom_padding=”80px||200px||false|false” global_colors_info=”{}”][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=”4.27.3″ _module_preset=”default” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.27.3″ _module_preset=”default” global_colors_info=”{}”][et_pb_button button_url=”https:\/new-products-development\/” url_new_window=”on” button_text=”Discover More” button_alignment=”center” _builder_version=”4.27.3″ _module_preset=”default” filter_hue_rotate=”113deg” filter_saturate=”63%” locked=”off” global_colors_info=”{}”][\/et_pb_button][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ admin_label=”Servicio #2″ module_id=”new” _builder_version=”4.19.0″ _module_preset=”default” background_color=”#f2f2f2″ locked=”off” collapsed=”on” global_colors_info=”{}”][et_pb_row _builder_version=”4.19.0″ _module_preset=”default” width_tablet=”” width_phone=”” width_last_edited=”on|desktop” max_width=”1200px” max_width_tablet=”1200px” max_width_phone=”1200px” max_width_last_edited=”on|desktop” custom_margin=”||||false|false” custom_padding=”||2px||false|false” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.16″ _module_preset=”default” custom_padding=”0px|0px|0px|0px|false|false” global_colors_info=”{}”][et_pb_divider color=”#cc00e2″ _builder_version=”4.16″ _module_preset=”default” custom_margin=”6px|||||” global_colors_info=”{}”][\/et_pb_divider][et_pb_text quote_border_color=”#8c1d6c” module_id=”reg” _builder_version=”4.27.0″ text_font=”Montserrat||||||||” text_text_color=”#000000″ text_font_size=”16px” text_line_height=”1.8em” quote_font=”||||||||” header_font=”||||||||” header_2_font=”Montserrat||||||||” header_2_text_color=”#8c1d6c” header_2_font_size=”30px” header_2_line_height=”1.4em” header_6_font=”Montserrat|600||on|||||” header_6_text_color=”#088b8c” header_6_font_size=”16px” header_6_letter_spacing=”2px” header_6_line_height=”1.5em” background_layout=”dark” max_width=”600px” custom_margin=”-7px||-30px||false|false” custom_padding=”||0px||false|false” header_2_font_size_tablet=”” header_2_font_size_phone=”24px” header_2_font_size_last_edited=”on|phone” locked=”off” global_colors_info=”{}”]<\/p>\n

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      Regulatory Affairs\u00a0<\/strong><\/span><\/h2>\n<\/blockquote>\n

      [\/et_pb_text][et_pb_text _builder_version=”4.19.0″ _module_preset=”default” custom_margin=”|||30px|false|false” custom_margin_tablet=”|||30px|false|false” custom_margin_phone=”50px|||0px|false|false” custom_margin_last_edited=”on|phone” custom_padding_tablet=”” custom_padding_phone=”” custom_padding_last_edited=”on|phone” global_colors_info=”{}”]<\/p>\n

      Pharmaceutical Innovation Services, S.L. offers great expertise in setting the best regulatory strategy to meet customers’ needs across different markets. Establishing the right regulatory strategy is a key aspect of the project, as it contributes from the outset to reducing the time to market, while also supporting feasibility assessments, timelines and costs management. In this area, Pharmaceutical Innovation Services, S.L. can carry out the following regulatory services:<\/p>\n

      [\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=”1_3,1_3,1_3″ _builder_version=”4.27.4″ _module_preset=”default” width_tablet=”” width_phone=”” width_last_edited=”on|desktop” max_width=”1200px” max_width_tablet=”1200px” max_width_phone=”1200px” max_width_last_edited=”on|desktop” global_colors_info=”{}”][et_pb_column type=”1_3″ _builder_version=”4.27.4″ _module_preset=”default” background_video_mp4=”https:\/\/pharmaceuticalinnovation.es\/wp-content\/uploads\/2022\/09\/regulatory-1.mov” custom_padding=”80px||200px||false|false” global_colors_info=”{}”][\/et_pb_column][et_pb_column type=”1_3″ _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][et_pb_text _builder_version=”4.19.0″ _module_preset=”default” global_colors_info=”{}”]<\/p>\n

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      • Advice on the regulatory strategy of the product.<\/span><\/li>\n
      • Assistance to request Scientific Advice from all Health Authorities.<\/span><\/li>\n
      • Audit of Dossiers and GAP analysis.<\/span><\/li>\n
      • Preparation of the dossier in eCTD format and submission of registration dossiers at global level. Including Pre-clinical and Clinical sections, Investigational Medicinal Product Dossiers (IMPDs) dossiers, and DL response.<\/span><\/li>\n
      • Full Regulatory Dossier Management and upload into eCTD Software (Latok).<\/li>\n
      • Collaboration for in-licensing and out-licensing.<\/span><\/span><\/li>\n<\/ul>\n

        [\/et_pb_text][\/et_pb_column][et_pb_column type=”1_3″ _builder_version=”4.27.4″ _module_preset=”default” background_enable_video_mp4=”off” global_colors_info=”{}”][et_pb_text _builder_version=”4.27.0″ _module_preset=”default” custom_margin=”||||false|false” custom_margin_tablet=”||||false|false” custom_margin_phone=”-40px||||false|false” custom_margin_last_edited=”on|phone” custom_padding_tablet=”” custom_padding_phone=”” custom_padding_last_edited=”on|phone” global_colors_info=”{}”]<\/p>\n

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        • Life-cycle management of the medicinal product. Maintenance of a medicinal product including regulatory variations, renewals and notifications.<\/li>\n
        • Elaboration of Readability test.<\/span><\/li>\n
        • Preparation of documentation for the application for registration of the company as a Marketing Authorization Holder (MAH), including the following items: Quality and Pharmacovigilance documentation and support for implementing GDP certification.<\/li>\n<\/ul>\n

          [\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=”4.27.3″ _module_preset=”default” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.27.3″ _module_preset=”default” global_colors_info=”{}”][et_pb_button button_url=”https:\/pharmaceuticals-regulatory-affairs\/” url_new_window=”on” button_text=”Discover More” button_alignment=”center” _builder_version=”4.27.3″ _module_preset=”default” filter_hue_rotate=”113deg” filter_saturate=”63%” locked=”off” global_colors_info=”{}”][\/et_pb_button][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ admin_label=”Servicio #3″ module_id=”new” _builder_version=”4.16″ _module_preset=”default” background_color=”#FFFFFF” locked=”off” collapsed=”on” global_colors_info=”{}”][et_pb_row _builder_version=”4.19.0″ _module_preset=”default” width_tablet=”” width_phone=”” width_last_edited=”on|desktop” max_width=”1200px” max_width_tablet=”1200px” max_width_phone=”1200px” max_width_last_edited=”on|desktop” custom_margin=”||||false|false” custom_padding=”||2px||false|false” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.16″ _module_preset=”default” custom_padding=”0px|0px|0px|0px|false|false” global_colors_info=”{}”][et_pb_divider color=”#cc00e2″ _builder_version=”4.16″ _module_preset=”default” custom_margin=”6px|||||” global_colors_info=”{}”][\/et_pb_divider][et_pb_text quote_border_color=”#8c1d6c” module_id=”tech” _builder_version=”4.19.0″ text_font=”Montserrat||||||||” text_text_color=”#000000″ text_font_size=”16px” text_line_height=”1.8em” quote_font=”||||||||” header_font=”||||||||” header_2_font=”Montserrat||||||||” header_2_text_color=”#8c1d6c” header_2_font_size=”30px” header_2_line_height=”1.4em” header_6_font=”Montserrat|600||on|||||” header_6_text_color=”#088b8c” header_6_font_size=”16px” header_6_letter_spacing=”2px” header_6_line_height=”1.5em” background_layout=”dark” max_width=”801px” custom_margin=”-7px||-30px||false|false” custom_padding=”||0px||false|false” header_2_font_size_tablet=”” header_2_font_size_phone=”24px” header_2_font_size_last_edited=”on|phone” locked=”off” global_colors_info=”{}”]<\/p>\n

          \n

          CMC (Chemistry, Manufacturing, and Controls): Manufacturing and technology transfer<\/strong><\/span><\/h2>\n<\/blockquote>\n

          [\/et_pb_text][et_pb_text admin_label=”Text” _builder_version=”4.19.0″ _module_preset=”default” custom_margin=”|||30px|false|false” custom_margin_tablet=”|||30px|false|false” custom_margin_phone=”50px|||0px|false|false” custom_margin_last_edited=”on|desktop” custom_padding_tablet=”” custom_padding_phone=”” custom_padding_last_edited=”on|desktop” global_colors_info=”{}”]<\/p>\n

          The transfer of technology and scientific knowledge is essential to ensure the industrial implementation, an efficient supply chain, and commercial production.This includes providing guidance and support for the scale-up and integration of manufacturing processes and analytical methods within the host company.<\/p>\n

          [\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=”1_3,1_3,1_3″ _builder_version=”4.27.4″ _module_preset=”default” width_tablet=”” width_phone=”” width_last_edited=”on|desktop” max_width=”1200px” max_width_tablet=”1200px” max_width_phone=”1200px” max_width_last_edited=”on|desktop” global_colors_info=”{}”][et_pb_column type=”1_3″ _builder_version=”4.27.4″ _module_preset=”default” background_video_mp4=”https:\/\/pharmaceuticalinnovation.es\/wp-content\/uploads\/2022\/09\/Manufacturing-Area-1.mov” custom_padding=”80px||200px||false|false” global_colors_info=”{}”][\/et_pb_column][et_pb_column type=”1_3″ _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][et_pb_text _builder_version=”4.19.0″ _module_preset=”default” custom_margin=”||||false|false” global_colors_info=”{}”]<\/p>\n

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          • \n
            Writing and review of Active Ingredient Permitted Daily Exposure (PDE) Report.<\/div>\n<\/li>\n
          • Nitrosamines Risk assesment Report.<\/span><\/li>\n
          • \n

            <\/span>Risk assessment for cross-contamination prevention.<\/span><\/p>\n<\/li>\n

          • \n
            CMO network optimization<\/span><\/div>\n<\/li>\n
          • \n
            Supply chain analysis and simplification<\/span><\/div>\n<\/li>\n
          • \n
            Inventory management<\/span><\/div>\n<\/li>\n
          • \n
            Production planning evaluation<\/span><\/span><\/div>\n<\/li>\n<\/ul>\n

            [\/et_pb_text][\/et_pb_column][et_pb_column type=”1_3″ _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][et_pb_text _builder_version=”4.19.0″ _module_preset=”default” custom_margin=”||||false|false” custom_margin_tablet=”||||false|false” custom_margin_phone=”-40px||||false|false” custom_margin_last_edited=”on|phone” custom_padding_tablet=”” custom_padding_phone=”” custom_padding_last_edited=”on|phone” global_colors_info=”{}”]<\/p>\n

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            • \n
              Trouble shooting of mature products to improve robustness and cost efficiency<\/span><\/div>\n<\/li>\n
            • QA assistance during manufacturing process<\/span><\/li>\n
            • Lifecycle management: Project management for the addiction of new API source, new manufacturing site, change of excipients\/equipment, change of equipment, improvement of manufacturing process, etc.<\/span><\/li>\n<\/ul>\n

              [\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=”4.27.3″ _module_preset=”default” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.27.3″ _module_preset=”default” global_colors_info=”{}”][et_pb_button button_url=”https:\/cmc-manufacturing-technology-transfer\/” url_new_window=”on” button_text=”Discover More” button_alignment=”center” _builder_version=”4.27.3″ _module_preset=”default” filter_hue_rotate=”113deg” filter_saturate=”63%” locked=”off” global_colors_info=”{}”][\/et_pb_button][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ admin_label=”Servicio #4″ module_id=”new” _builder_version=”4.19.0″ _module_preset=”default” background_color=”#f2f2f2″ locked=”off” collapsed=”on” global_colors_info=”{}”][et_pb_row _builder_version=”4.19.0″ _module_preset=”default” width_tablet=”” width_phone=”” width_last_edited=”on|desktop” max_width=”1200px” max_width_tablet=”1200px” max_width_phone=”1200px” max_width_last_edited=”on|desktop” custom_margin=”||||false|false” custom_padding=”||2px||false|false” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.16″ _module_preset=”default” custom_padding=”0px|0px|0px|0px|false|false” global_colors_info=”{}”][et_pb_divider color=”#cc00e2″ _builder_version=”4.16″ _module_preset=”default” custom_margin=”6px|||||” global_colors_info=”{}”][\/et_pb_divider][et_pb_text quote_border_color=”#8c1d6c” module_id=”risk” _builder_version=”4.19.0″ text_font=”Montserrat||||||||” text_text_color=”#000000″ text_font_size=”16px” text_line_height=”1.8em” quote_font=”||||||||” header_font=”||||||||” header_2_font=”Montserrat||||||||” header_2_text_color=”#8c1d6c” header_2_font_size=”30px” header_2_line_height=”1.4em” header_6_font=”Montserrat|600||on|||||” header_6_text_color=”#088b8c” header_6_font_size=”16px” header_6_letter_spacing=”2px” header_6_line_height=”1.5em” background_layout=”dark” max_width=”710px” custom_margin=”-7px||-30px||false|false” custom_padding=”||0px||false|false” header_2_font_size_tablet=”” header_2_font_size_phone=”24px” header_2_font_size_last_edited=”on|phone” locked=”off” global_colors_info=”{}”]<\/p>\n

              \n

              Risk assessment and QA & Compliance<\/strong><\/span><\/span><\/h2>\n<\/blockquote>\n

              [\/et_pb_text][et_pb_text _builder_version=”4.19.0″ _module_preset=”default” custom_margin=”||-30px|30px|false|false” custom_margin_tablet=”||-30px|30px|false|false” custom_margin_phone=”50px|||0px|false|false” custom_margin_last_edited=”on|phone” custom_padding_tablet=”” custom_padding_phone=”” custom_padding_last_edited=”on|phone” global_colors_info=”{}”]<\/p>\n

              Quality risk management is a systematic process of assessing, controlling, communicating and reviewing risks that affect the quality of a medicinal product. Pharmaceutical Innovation Services, S.L. identifies risks throughout the entire product lifecycle in order to increase the level of quality without compromising regulatory compliance.<\/p>\n

               <\/p>\n

              [\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=”1_3,1_3,1_3″ _builder_version=”4.27.4″ _module_preset=”default” global_colors_info=”{}”][et_pb_column type=”1_3″ _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][et_pb_text _builder_version=”4.19.0″ _module_preset=”default” custom_margin=”|||-30px|false|false” custom_margin_tablet=”|||-30px|false|false” custom_margin_phone=”|||0px|false|false” custom_margin_last_edited=”on|phone” custom_padding_tablet=”” custom_padding_phone=”” custom_padding_last_edited=”on|phone” global_colors_info=”{}”]<\/p>\n

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              • Elemental Impurities Risk Asessment\u00a0 (ICH Q3D).<\/span><\/li>\n
              • Support in the execution and evaluation of GXP audits and follow up of defficiencies and CAPA plan. Support in evaluation of effectiveness.<\/span><\/li>\n<\/ul>\n

                [\/et_pb_text][\/et_pb_column][et_pb_column type=”1_3″ _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][et_pb_text _builder_version=”4.27.4″ _module_preset=”default” custom_margin_tablet=”” custom_margin_phone=”-40px||||false|false” custom_margin_last_edited=”on|phone” custom_padding_tablet=”” custom_padding_phone=”” custom_padding_last_edited=”on|phone” global_colors_info=”{}”]<\/p>\n

                  \n
                • Preparation of SOPs (controlled standard operating procedures), working instructions and\/or forms.<\/li>\n
                • Advice and technical support to implement Good Distribution Practices (GPD), assisting Marketing Authorization Holders (MAHs) in fulfilling all requirements until obtaining Authorization and GDP certification.<\/li>\n<\/ul>\n

                  [\/et_pb_text][\/et_pb_column][et_pb_column type=”1_3″ _builder_version=”4.27.4″ _module_preset=”default” background_video_mp4=”https:\/\/pharmaceuticalinnovation.es\/wp-content\/uploads\/2022\/09\/risk.mov” custom_padding=”80px||200px||false|false” global_colors_info=”{}”][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=”4.27.3″ _module_preset=”default” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.27.3″ _module_preset=”default” global_colors_info=”{}”][et_pb_button button_url=”https:\/risk-assessment-qa-compliance\/” url_new_window=”on” button_text=”Discover More” button_alignment=”center” _builder_version=”4.27.3″ _module_preset=”default” filter_hue_rotate=”113deg” filter_saturate=”63%” locked=”off” global_colors_info=”{}”][\/et_pb_button][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ admin_label=”Servicio #5″ module_id=”new” _builder_version=”4.19.0″ _module_preset=”default” background_color=”#ffffff” locked=”off” collapsed=”on” global_colors_info=”{}”][et_pb_row _builder_version=”4.19.0″ _module_preset=”default” width_tablet=”” width_phone=”” width_last_edited=”on|desktop” max_width=”1200px” max_width_tablet=”1200px” max_width_phone=”1200px” max_width_last_edited=”on|desktop” custom_margin=”||||false|false” custom_padding=”||2px||false|false” module_alignment_tablet=”” module_alignment_phone=”” module_alignment_last_edited=”on|desktop” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.16″ _module_preset=”default” custom_padding=”0px|0px|0px|0px|false|false” global_colors_info=”{}”][et_pb_divider color=”#cc00e2″ _builder_version=”4.16″ _module_preset=”default” custom_margin=”6px|||||” global_colors_info=”{}”][\/et_pb_divider][et_pb_text quote_border_color=”#8c1d6c” module_id=”vigilance” _builder_version=”4.19.0″ text_font=”Montserrat||||||||” text_text_color=”#000000″ text_font_size=”16px” text_line_height=”1.8em” quote_font=”||||||||” header_font=”||||||||” header_2_font=”Montserrat||||||||” header_2_text_color=”#8c1d6c” header_2_font_size=”30px” header_2_line_height=”1.4em” header_6_font=”Montserrat|600||on|||||” header_6_text_color=”#088b8c” header_6_font_size=”16px” header_6_letter_spacing=”2px” header_6_line_height=”1.5em” background_layout=”dark” max_width=”600px” custom_margin=”-7px||-30px||false|false” custom_padding=”||0px||false|false” header_2_font_size_tablet=”” header_2_font_size_phone=”24px” header_2_font_size_last_edited=”on|phone” locked=”off” global_colors_info=”{}”]<\/p>\n

                  \n

                  Pharmacovigilance<\/strong><\/span><\/h2>\n<\/blockquote>\n

                  [\/et_pb_text][et_pb_text _builder_version=”4.19.0″ _module_preset=”default” custom_margin=”|||30px|false|false” custom_margin_tablet=”|||30px|false|false” custom_margin_phone=”50px|||0px|false|false” custom_margin_last_edited=”on|desktop” custom_padding_tablet=”” custom_padding_phone=”” custom_padding_last_edited=”on|desktop” global_colors_info=”{}”]<\/p>\n

                  Complete package of Pharmacovigilance (PhV) services is provided as we count on a global team of PhV experts including experienced PhV physicians and medical writing group. We will ensure that your company obtains high quality sevices and fulfils the regulatory requirements and industry standards.<\/p>\n

                  Helping our customers meet demanding requirements, along with managing the risk-benefit profile of their products, we seek to maximize product marketing potential, while ensuring patient safety. From outsourcing of individual activities to setting up and managing an effective and efficient global pharmacovigilance system, we provide tailor-made solutions for specific requirements.<\/p>\n

                  [\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=”1_3,1_3,1_3″ _builder_version=”4.27.4″ _module_preset=”default” width_tablet=”” width_phone=”” width_last_edited=”on|desktop” max_width=”1200px” max_width_tablet=”1200px” max_width_phone=”1200px” max_width_last_edited=”on|desktop” module_alignment_tablet=”” module_alignment_phone=”” module_alignment_last_edited=”on|desktop” global_colors_info=”{}”][et_pb_column type=”1_3″ _builder_version=”4.19.0″ _module_preset=”default” custom_padding=”|||30px|false|false” global_colors_info=”{}”][et_pb_text _builder_version=”4.19.0″ _module_preset=”default” custom_margin=”|-452px|||false|false” custom_margin_tablet=”||||false|false” custom_margin_phone=”|||-30px|false|false” custom_margin_last_edited=”on|phone” custom_padding_tablet=”” custom_padding_phone=”” custom_padding_last_edited=”on|phone” global_colors_info=”{}”]<\/p>\n

                    \n
                  • Risk Management Plan (RMP) elaboration<\/li>\n
                  • Global and Local Literature searches (frequency to be defined with customers), reconcilation of cases and signal detection.<\/li>\n
                  • Management of ICSR and L2A cases (EudraVigilance).<\/li>\n
                  • Maintenance of Extended EudraVigilance Medicinal Product Dictionary (xEVMPD).<\/li>\n
                  • Pharmacovigilance training.<\/li>\n
                  • Audits to Pharmacovigilance System of third parties (including vendors and\/or partners).<\/li>\n
                  • Support in case of inspection by the Competent Authority.<\/li>\n
                  • Management of urgent safety communications with Competent Authorities; Monitoring of PhV perfromance, management of deviations and CAPAs<\/li>\n<\/ul>\n

                    [\/et_pb_text][\/et_pb_column][et_pb_column type=”1_3″ _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][\/et_pb_column][et_pb_column type=”1_3″ _builder_version=”4.27.4″ _module_preset=”default” background_video_mp4=”https:\/\/pharmaceuticalinnovation.es\/wp-content\/uploads\/2022\/09\/vigilance.mov” custom_padding=”80px||200px||false|false” global_colors_info=”{}”][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=”4.27.3″ _module_preset=”default” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.27.3″ _module_preset=”default” global_colors_info=”{}”][et_pb_button button_url=”https:\/pharmacovigilance-services\/” url_new_window=”on” button_text=”Discover More” button_alignment=”center” _builder_version=”4.27.3″ _module_preset=”default” filter_hue_rotate=”113deg” filter_saturate=”63%” locked=”off” global_colors_info=”{}”][\/et_pb_button][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ admin_label=”Servicio #6″ module_id=”new” _builder_version=”4.19.0″ _module_preset=”default” background_color=”#f2f2f2″ locked=”off” collapsed=”on” global_colors_info=”{}”][et_pb_row _builder_version=”4.19.0″ _module_preset=”default” width_tablet=”” width_phone=”” width_last_edited=”on|desktop” max_width=”1200px” max_width_tablet=”1200px” max_width_phone=”1200px” max_width_last_edited=”on|desktop” custom_margin=”||||false|false” custom_padding=”||2px||false|false” collapsed=”on” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.16″ _module_preset=”default” custom_padding=”0px|0px|0px|0px|false|false” global_colors_info=”{}”][et_pb_divider color=”#cc00e2″ _builder_version=”4.16″ _module_preset=”default” custom_margin=”6px|||||” global_colors_info=”{}”][\/et_pb_divider][et_pb_text quote_border_color=”#8c1d6c” module_id=”clinical” _builder_version=”4.19.0″ text_font=”Montserrat||||||||” text_text_color=”#000000″ text_font_size=”16px” text_line_height=”1.8em” quote_font=”||||||||” header_font=”||||||||” header_2_font=”Montserrat||||||||” header_2_text_color=”#8c1d6c” header_2_font_size=”30px” header_2_line_height=”1.4em” header_6_font=”Montserrat|600||on|||||” header_6_text_color=”#088b8c” header_6_font_size=”16px” header_6_letter_spacing=”2px” header_6_line_height=”1.5em” background_layout=”dark” max_width=”600px” custom_margin=”-7px||-30px||false|false” custom_padding=”||0px||false|false” header_2_font_size_tablet=”” header_2_font_size_phone=”24px” header_2_font_size_last_edited=”on|phone” locked=”off” global_colors_info=”{}”]<\/p>\n

                    \n

                    Clinical Studies<\/strong><\/h2>\n<\/blockquote>\n

                    [\/et_pb_text][et_pb_text _builder_version=”4.19.0″ _module_preset=”default” width_tablet=”” width_phone=”” width_last_edited=”on|desktop” max_width_tablet=”” max_width_phone=”” max_width_last_edited=”on|desktop” custom_margin=”|||30px|false|false” custom_margin_tablet=”|||30px|false|false” custom_margin_phone=”50px|||0px|false|false” custom_margin_last_edited=”on|desktop” custom_padding_tablet=”” custom_padding_phone=”” custom_padding_last_edited=”on|desktop” global_colors_info=”{}”]<\/p>\n

                    Pharmaceutical Innovation Services, S.L. will support you in clinical data requirements as well as bioequivalence guideline. Our medical writers are experienced in managing updates to clinical evaluation and performance evaluation plans and reports to guarantee compliance. In a case where additional clinical data is required, we help you determine the appropriate clinical strategy, and we offer support with the design and set-up of the clinical study, including obtaining all of the necessary approvals.<\/p>\n

                    [\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=”1_3,1_3,1_3″ _builder_version=”4.27.4″ _module_preset=”default” width_tablet=”” width_phone=”” width_last_edited=”on|desktop” max_width=”1200px” max_width_tablet=”1200px” max_width_phone=”1200px” max_width_last_edited=”on|desktop” collapsed=”on” global_colors_info=”{}”][et_pb_column type=”1_3″ _builder_version=”4.27.4″ _module_preset=”default” background_video_mp4=”https:\/\/pharmaceuticalinnovation.es\/wp-content\/uploads\/2022\/09\/studies.mov” custom_padding=”80px||200px||false|false” custom_padding_tablet=”80px||200px||false|false” custom_padding_phone=”80px||200px||false|false” custom_padding_last_edited=”on|desktop” global_colors_info=”{}”][\/et_pb_column][et_pb_column type=”1_3″ _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][et_pb_text _builder_version=”4.19.0″ _module_preset=”default” global_colors_info=”{}”]<\/p>\n

                      \n
                    • Scientific advice.<\/li>\n
                    • Elaboration and submission of Scientific Advisories to the Health Authorities.<\/li>\n
                    • Selection and qualification of CROs, Research Centres and Phase I units.<\/li>\n<\/ul>\n

                      [\/et_pb_text][\/et_pb_column][et_pb_column type=”1_3″ _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][et_pb_text _builder_version=”4.19.0″ _module_preset=”default” custom_margin_tablet=”” custom_margin_phone=”-40px||||false|false” custom_margin_last_edited=”on|phone” custom_padding_tablet=”” custom_padding_phone=”” custom_padding_last_edited=”on|phone” global_colors_info=”{}”]<\/p>\n

                        \n
                      • Start-up and monitoring of Clinical Studies (Phases I-IV).<\/li>\n
                      • Preparation of Investigational Medicinal Product Dossiers (IMPDs).<\/span><\/li>\n
                      • Support on Bioequivalence studies and Biowaiver justification.<\/li>\n<\/ul>\n

                        [\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=”4.27.3″ _module_preset=”default” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.27.3″ _module_preset=”default” global_colors_info=”{}”][et_pb_button button_url=”https:\/service-support-clinical-studies\/” url_new_window=”on” button_text=”Discover More” button_alignment=”center” _builder_version=”4.27.3″ _module_preset=”default” filter_hue_rotate=”113deg” filter_saturate=”63%” locked=”off” global_colors_info=”{}”][\/et_pb_button][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ admin_label=”Servicio #5″ module_id=”new” _builder_version=”4.19.0″ _module_preset=”default” background_color=”#ffffff” locked=”off” collapsed=”on” global_colors_info=”{}”][et_pb_row _builder_version=”4.19.0″ _module_preset=”default” width_tablet=”” width_phone=”” width_last_edited=”on|desktop” max_width=”1200px” max_width_tablet=”1200px” max_width_phone=”1200px” max_width_last_edited=”on|desktop” custom_margin=”||||false|false” custom_padding=”||2px||false|false” module_alignment_tablet=”” module_alignment_phone=”” module_alignment_last_edited=”on|desktop” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.16″ _module_preset=”default” custom_padding=”0px|0px|0px|0px|false|false” global_colors_info=”{}”][et_pb_divider color=”#cc00e2″ _builder_version=”4.16″ _module_preset=”default” custom_margin=”6px|||||” global_colors_info=”{}”][\/et_pb_divider][et_pb_text quote_border_color=”#8c1d6c” module_id=”vigilance” _builder_version=”4.27.0″ text_font=”Montserrat||||||||” text_text_color=”#000000″ text_font_size=”16px” text_line_height=”1.8em” quote_font=”||||||||” header_font=”||||||||” header_2_font=”Montserrat||||||||” header_2_text_color=”#8c1d6c” header_2_font_size=”30px” header_2_line_height=”1.4em” header_6_font=”Montserrat|600||on|||||” header_6_text_color=”#088b8c” header_6_font_size=”16px” header_6_letter_spacing=”2px” header_6_line_height=”1.5em” background_layout=”dark” max_width=”600px” custom_margin=”-7px||-30px||false|false” custom_padding=”||0px||false|false” header_2_font_size_tablet=”” header_2_font_size_phone=”24px” header_2_font_size_last_edited=”on|phone” locked=”off” global_colors_info=”{}”]<\/p>\n

                        \n

                        MAH Services<\/strong><\/span><\/h2>\n<\/blockquote>\n

                        [\/et_pb_text][et_pb_text _builder_version=”4.27.0″ _module_preset=”default” custom_margin=”|||30px|false|false” custom_margin_tablet=”|||30px|false|false” custom_margin_phone=”50px|||0px|false|false” custom_margin_last_edited=”on|desktop” custom_padding_tablet=”” custom_padding_phone=”” custom_padding_last_edited=”on|desktop” global_colors_info=”{}”]<\/p>\n

                        The Marketing Authorization Holder (MAH)<\/b> term refers to a company or other legal entity that has the authorisation to market a medicine in one, several or all European Union Member States. MAH is the entity which takes the responsibility<\/b> for ensuring compliance with the standards set out in European Union (EU) legislation and guidelines.<\/p>\n

                        \n

                        [\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=”2_5,3_5″ _builder_version=”4.27.0″ _module_preset=”default” global_colors_info=”{}”][et_pb_column type=”2_5″ _builder_version=”4.27.0″ _module_preset=”default” global_colors_info=”{}”][et_pb_video src_webm=”https:\/\/pharmaceuticalinnovation.es\/wp-content\/uploads\/2024\/10\/MAH-SERVICES.mp4″ _builder_version=”4.27.4″ _module_preset=”default” custom_padding=”|||0px||” global_colors_info=”{}”][\/et_pb_video][\/et_pb_column][et_pb_column type=”3_5″ _builder_version=”4.27.0″ _module_preset=”default” global_colors_info=”{}”][et_pb_text _builder_version=”4.27.0″ _module_preset=”default” global_colors_info=”{}”]<\/p>\n

                        At Pharmaceutical Innovation Services, S.L., we can act as the Marketing Authorization Holder (MAH) for your medicinal products.<\/p>\n

                        We assist companies in registrations of medicinal products under National Procedure (NP), Centralized Procedure (CP), Decentralized Procedure (DCP) or Mutual Recognition Procedure (MRP) while acting as the MAH.<\/p>\n

                        We may also assist in commercial transactions of confidential sale or purchasing of marketing authorizations (MA) for each medicinal product or their dossiers, or in any other case where you need us to represent your company as the MAH under our name.<\/p>\n

                        [\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=”4.27.3″ _module_preset=”default” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.27.3″ _module_preset=”default” global_colors_info=”{}”][et_pb_button button_url=”https:\/reliable-mah-services\/” url_new_window=”on” button_text=”Discover More” button_alignment=”center” _builder_version=”4.27.3″ _module_preset=”default” filter_hue_rotate=”113deg” filter_saturate=”63%” locked=”off” global_colors_info=”{}”][\/et_pb_button][\/et_pb_column][\/et_pb_row][\/et_pb_section]<\/p>\n","protected":false},"excerpt":{"rendered":"

                        Pharmaceutical Development, Regulatory Affairs, Quality Assurance and Pharmacovigilance Services Our Pharmaceutical Development Services We are proud to provide a wide range of high-quality services in the following areas: New Product Development Innovation, design and\/or development of new products are fundamental activities in order to face the dynamic pharma market.Pharmaceutical Innovation Services, S.L. has a multidisciplinary […]<\/p>\n","protected":false},"author":1,"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":"","footnotes":""},"class_list":["post-313","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/pharmaceuticalinnovation.es\/es\/wp-json\/wp\/v2\/pages\/313","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/pharmaceuticalinnovation.es\/es\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/pharmaceuticalinnovation.es\/es\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/pharmaceuticalinnovation.es\/es\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/pharmaceuticalinnovation.es\/es\/wp-json\/wp\/v2\/comments?post=313"}],"version-history":[{"count":17,"href":"https:\/\/pharmaceuticalinnovation.es\/es\/wp-json\/wp\/v2\/pages\/313\/revisions"}],"predecessor-version":[{"id":1690,"href":"https:\/\/pharmaceuticalinnovation.es\/es\/wp-json\/wp\/v2\/pages\/313\/revisions\/1690"}],"wp:attachment":[{"href":"https:\/\/pharmaceuticalinnovation.es\/es\/wp-json\/wp\/v2\/media?parent=313"}],"curies":[{"name":"Gracias","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}