{"id":14,"date":"2020-08-18T21:15:54","date_gmt":"2020-08-18T21:15:54","guid":{"rendered":"https:\/\/pamareis.com\/?page_id=14"},"modified":"2021-01-20T11:08:34","modified_gmt":"2021-01-20T11:08:34","slug":"services","status":"publish","type":"page","link":"https:\/\/pamareis.com\/en\/services\/","title":{"rendered":"Services"},"content":{"rendered":"

[vc_row css_animation=”” row_type=”row” use_row_as_full_screen_section=”no” type=”full_width” angled_section=”no” text_align=”left” background_image_as_pattern=”without_pattern”][vc_column][vc_single_image image=”473″ img_size=”full” alignment=”center” qode_css_animation=”” css=”.vc_custom_1604576361890{background-color: #ffffff !important;background-position: center !important;background-repeat: no-repeat !important;background-size: cover !important;}”][vc_row_inner row_type=”row” type=”grid” text_align=”left” css_animation=”” css=”.vc_custom_1605635418749{background-color: #efefef !important;}”][vc_column_inner width=”1\/6″][\/vc_column_inner][vc_column_inner width=”4\/6″][vc_empty_space height=”72px”][vc_column_text]Pama Reis Consulting<\/strong> offers a wide range of\u00a0 services, be it a one-off or a long-term project with hourly or monthly fees.<\/p>\n

Browse below some of the services we currently provide.[\/vc_column_text][vc_empty_space][vc_column_text]<\/p>\n

Looking for additional information? Please contact us at info@pamareis.com<\/a>.<\/p>\n

[\/vc_column_text][\/vc_column_inner][vc_column_inner width=”1\/6″][\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row][vc_row css_animation=”” row_type=”row” use_row_as_full_screen_section=”no” type=”full_width” angled_section=”no” text_align=”left” background_image_as_pattern=”without_pattern” z_index=”” background_color=”#ffffff” css=”.vc_custom_1605635458195{background-color: #efefef !important;}”][vc_column][vc_empty_space][\/vc_column][\/vc_row][vc_row css_animation=”” row_type=”row” use_row_as_full_screen_section=”no” type=”full_width” angled_section=”no” text_align=”left” background_image_as_pattern=”without_pattern” css=”.vc_custom_1598305573123{background-color: #ffffff !important;}” z_index=””][vc_column width=”1\/6″ css=”.vc_custom_1598205196019{background-color: #ffffff !important;}”][\/vc_column][vc_column width=”2\/6″ css=”.vc_custom_1598305600138{background-color: #ffffff !important;}”]

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\n\n\t \n New MA applications and MA maintenance <\/span>\n<\/span>\n\n \n <\/span>\n <\/span>\n <\/span>\n<\/span>\n<\/h6>\n
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\n [vc_column_text]<\/p>\n
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  • New MA applications \u2013 Preparation, submission and maintenance (national, mutual recognition, decentralized and centralized procedures, in NeeS and eCTD)<\/li>\n
  • Compliance<\/li>\n
  • Preparation\/Review of MA dossier documentation<\/li>\n
  • Regular contact with Competent Authorities<\/li>\n
  • SmPC, PIL and Labelling review<\/li>\n
  • MA variations Type I (IAin, IA, IB) and Type II<\/li>\n
  • MA renewal<\/li>\n
  • MAH transference<\/li>\n<\/ul>\n

    [\/vc_column_text] <\/div>\n<\/div>

    \n\n\t \n Economic Assessment <\/span>\n<\/span>\n\n \n <\/span>\n <\/span>\n <\/span>\n<\/span>\n<\/h6>\n
    \n
    \n [vc_column_text]<\/p>\n
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    • Prices – new application and annual review<\/li>\n
    • Previous assessment of medicinal products<\/li>\n
    • Reimbursement application<\/li>\n
    • Early Access Program<\/li>\n<\/ul>\n

      [\/vc_column_text] <\/div>\n<\/div>

      \n\n\t \n Marketing <\/span>\n<\/span>\n\n \n <\/span>\n <\/span>\n <\/span>\n<\/span>\n<\/h6>\n
      \n
      \n [vc_column_text]<\/p>\n
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      • Review of promotional materials<\/li>\n
      • Notification of promotional materials to the Competent Authorities<\/li>\n
      • Publicity and Transparence Management (ToV, events)<\/li>\n<\/ul>\n

        [\/vc_column_text] <\/div>\n<\/div>

        \n\n\t \n Pharmacovigilance <\/span>\n<\/span>\n\n \n <\/span>\n <\/span>\n <\/span>\n<\/span>\n<\/h6>\n
        \n
        \n [vc_column_text]<\/p>\n
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        • Periodic Safety Update Reports<\/li>\n
        • Pharmacovilance SOPs<\/li>\n
        • Notification in Eudravigilance<\/li>\n
        • Bibliographic research in national and international literature<\/li>\n<\/ul>\n

          [\/vc_column_text] <\/div>\n<\/div>

          \n\n\t \n Licensing <\/span>\n<\/span>\n\n \n <\/span>\n <\/span>\n <\/span>\n<\/span>\n<\/h6>\n
          \n
          \n [vc_column_text]<\/p>\n
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          • Application to obtain distribution authorization for Medicinal Products<\/li>\n
          • Application to obtain distribution authorization for Medical Devices<\/li>\n
          • Preparation and implementation of Quality System<\/li>\n<\/ul>\n

            [\/vc_column_text] <\/div>\n<\/div><\/div>[vc_empty_space height=”52px”][\/vc_column][vc_column width=”2\/6″ css=”.vc_custom_1598305584656{background-color: #ffffff !important;}”]

            \n\t
            \n\n\t \n Medical Devices <\/span>\n<\/span>\n\n \n <\/span>\n <\/span>\n <\/span>\n<\/span>\n<\/h6>\n
            \n
            \n [vc_column_text]<\/p>\n
              \n
            • Preparation and review of labelling and instructions for use<\/li>\n
            • Notification to the Competent Authorities<\/li>\n
            • Medical Devices Vigilance<\/li>\n
            • CNP management (product national code)<\/li>\n<\/ul>\n

              [\/vc_column_text] <\/div>\n<\/div>

              \n\n\t \n Cosmetics <\/span>\n<\/span>\n\n \n <\/span>\n <\/span>\n <\/span>\n<\/span>\n<\/h6>\n
              \n
              \n [vc_column_text]<\/p>\n
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              • Product Information File (PIF)<\/li>\n
              • Safety Assessment Report<\/li>\n
              • Preparation and review of labelling and instructions for use<\/li>\n
              • Notification in CPNP<\/li>\n
              • Cosmetovigilance<\/li>\n
              • CNP management (product national code)<\/li>\n<\/ul>\n

                [\/vc_column_text] <\/div>\n<\/div>

                \n\n\t \n Food Supplements <\/span>\n<\/span>\n\n \n <\/span>\n <\/span>\n <\/span>\n<\/span>\n<\/h6>\n
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                \n [vc_column_text]<\/p>\n
                  \n
                • Preparation and review of labelling and instructions for use<\/li>\n
                • Notification to the Competent Authorities<\/li>\n
                • CNP management (product national code)<\/li>\n<\/ul>\n

                  [\/vc_column_text] <\/div>\n<\/div>

                  \n\n\t \n Other products <\/span>\n<\/span>\n\n \n <\/span>\n <\/span>\n <\/span>\n<\/span>\n<\/h6>\n
                  \n
                  \n [vc_column_text]<\/p>\n
                    \n
                  • Regulatory management of other health products (biocides, medicinal gases, herbal products, veterinary products)<\/li>\n<\/ul>\n

                    [\/vc_column_text] <\/div>\n<\/div>

                    \n\n\t \n Others <\/span>\n<\/span>\n\n \n <\/span>\n <\/span>\n <\/span>\n<\/span>\n<\/h6>\n
                    \n
                    \n [vc_column_text]<\/p>\n
                      \n
                    • Support in company meetings (in-house or other)<\/li>\n
                    • Medical Sales Representatives credentials<\/li>\n
                    • Training<\/li>\n
                    • Translation of scientific documents<\/li>\n
                    • Support in Quality Assurance Management<\/li>\n
                    • Support and presence in internal\/external audits and inspections<\/li>\n<\/ul>\n

                      [\/vc_column_text] <\/div>\n<\/div><\/div>[vc_empty_space height=”52px”][\/vc_column][vc_column width=”1\/6″][\/vc_column][\/vc_row][vc_row css_animation=”” row_type=”row” use_row_as_full_screen_section=”no” type=”full_width” angled_section=”no” text_align=”center” background_image_as_pattern=”without_pattern” z_index=”” background_color=”#ffffff” css=”.vc_custom_1605633625624{background-color: #efefef !important;}”][vc_column width=”1\/6″][\/vc_column][vc_column width=”4\/6″][vc_empty_space height=”52px”][vc_column_text]<\/p>\n

                      Quality Commitment<\/h3>\n

                      Each client will have[\/vc_column_text][vc_separator type=”small” position=”center” color=”#aaaaaa” thickness=”bold”][vc_empty_space][vc_row_inner row_type=”row” type=”full_width” text_align=”left” css_animation=””][vc_column_inner width=”1\/4″]

                      <\/i><\/span><\/div>
                      <\/h5>

                      Personal, independent and confidential support at all phases of the project<\/p><\/div><\/div><\/div>[\/vc_column_inner][vc_column_inner width=”1\/4″]

                      <\/i><\/span><\/div>
                      <\/h5>

                      Scrupulous fulfilment of all agreed deadlines and budgets<\/p><\/div><\/div><\/div>[\/vc_column_inner][vc_column_inner width=”1\/4″]

                      <\/i><\/span><\/div>
                      <\/h5>

                      Adaptation to personal requirements and organization, regarding meetings and in-house\/external work<\/p><\/div><\/div><\/div>[\/vc_column_inner][vc_column_inner width=”1\/4″]

                      <\/i><\/span><\/div>
                      <\/h5>

                      Full dedication to ongoing projects<\/p><\/div><\/div><\/div>[\/vc_column_inner][\/vc_row_inner][vc_empty_space][\/vc_column][vc_column width=”1\/6″][\/vc_column][\/vc_row]<\/p>\n","protected":false},"excerpt":{"rendered":"

                      [vc_row css_animation=”” row_type=”row” use_row_as_full_screen_section=”no” type=”full_width” angled_section=”no” text_align=”left” background_image_as_pattern=”without_pattern”][vc_column][vc_single_image image=”473″ img_size=”full” alignment=”center” qode_css_animation=”” css=”.vc_custom_1604576361890{background-color: #ffffff !important;background-position: center !important;background-repeat: no-repeat !important;background-size: cover !important;}”][vc_row_inner row_type=”row” type=”grid” text_align=”left” css_animation=”” css=”.vc_custom_1605635418749{background-color: #efefef !important;}”][vc_column_inner width=”1\/6″][\/vc_column_inner][vc_column_inner width=”4\/6″][vc_empty_space height=”72px”][vc_column_text]Pama Reis Consulting offers a wide range of\u00a0 services, be it a one-off or a…<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"full_width.php","meta":{"footnotes":""},"_links":{"self":[{"href":"https:\/\/pamareis.com\/en\/wp-json\/wp\/v2\/pages\/14"}],"collection":[{"href":"https:\/\/pamareis.com\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/pamareis.com\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/pamareis.com\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/pamareis.com\/en\/wp-json\/wp\/v2\/comments?post=14"}],"version-history":[{"count":86,"href":"https:\/\/pamareis.com\/en\/wp-json\/wp\/v2\/pages\/14\/revisions"}],"predecessor-version":[{"id":689,"href":"https:\/\/pamareis.com\/en\/wp-json\/wp\/v2\/pages\/14\/revisions\/689"}],"wp:attachment":[{"href":"https:\/\/pamareis.com\/en\/wp-json\/wp\/v2\/media?parent=14"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}