{"id":395,"date":"2023-03-01T11:00:06","date_gmt":"2023-03-01T11:00:06","guid":{"rendered":"https:\/\/www.ide-cso.com\/en\/?post_type=portfolio&p=395"},"modified":"2023-05-29T11:13:08","modified_gmt":"2023-05-29T11:13:08","slug":"regulatory-affairs","status":"publish","type":"portfolio","link":"https:\/\/www.ide-cso.com\/en\/services\/regulatory-affairs\/","title":{"rendered":"Regulatory Affairs"},"content":{"rendered":"

[vc_row el_id=”ruhsat-sahipligi-hizmetleri” css=”.vc_custom_1672651488871{padding-top: 35px !important;}”][vc_column][vc_custom_heading text=”Marketing Authorization Holder (MAH) Services” font_container=”tag:h3|text_align:left” use_theme_fonts=”yes”]

[vc_separator color=”custom” align=”align_left” border_width=”3″ el_width=”10″ style=”solid” accent_color=”#00acb7″ css=”.vc_custom_1672651375924{margin-top: -20px !important;}”]<\/div>[vc_column_text]We prepare and submit marketing authorization applications for human\/veterinary medicinal products, cosmetics or medical devices on behalf of companies and provide marketing authorization holder services[\/vc_column_text][\/vc_column][\/vc_row][vc_row el_id=”beseri-tibbi-urunler”][vc_column][vc_custom_heading text=”Human Medicinal Products” font_container=”tag:h3|text_align:left” use_theme_fonts=”yes”]
[vc_separator color=”custom” align=”align_left” border_width=”3″ el_width=”10″ style=”solid” accent_color=”#00acb7″ css=”.vc_custom_1672651384028{margin-top: -20px !important;}”]<\/div>[vc_column_text]Conventional small-molecule drugs, orphan drugs, biotechnological products and traditional herbal medicinal products <\/u><\/p>\n
    \n
  • Evaluation and reporting on dossiers of products for which filing a marketing authorization application is planned, in line with the current regulatory requirements and our experiences (GAP Analysis)<\/li>\n
  • Preparation of GMP\/Marketing Authorization prioritization application dossiers, including a justification report<\/li>\n
  • Preparation of GMP inspection application dossiers<\/li>\n
  • Organization of GMP inspection processes<\/li>\n
  • Providing expert support to GMP inspections on behalf of companies<\/li>\n
  • Preparation of marketing authorization dossiers for prescription drugs, over-the-counter drugs and traditional herbal medicinal products in CTD format for electronic submission (including the XML file) in accordance with current regulatory requirements, and submitting dossier electronically upon request<\/li>\n
  • Preparation of analysis dossiers, including analysis requirements<\/li>\n
  • Completion of the BA\/BE Form, submitted as part of the marketing authorization dossier, and preparation of the trial dossier in suitable format for application.<\/li>\n
  • Preparation of Type I and Type II variation applications and extension dossier and submitting these dossiers electronically upon request<\/li>\n
  • Preparation and update local SmPC & PIL<\/li>\n
  • Preparation of application dossiers for marketing authorization transfer and renewal<\/li>\n
  • Preparation of application dossiers for pricing<\/li>\n
  • Follow-up services on the official institutions and organizations<\/li>\n<\/ul>\n

    [\/vc_column_text][\/vc_column][\/vc_row][vc_row el_id=”veteriner-tibbi-urunler”][vc_column][vc_custom_heading text=”Veterinary Medicinal Products” font_container=”tag:h3|text_align:left” use_theme_fonts=”yes”]

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      \n
    • Preparation of marketing authorization application dossiers in accordance with current legal requirements and guidelines<\/li>\n
    • Preparation of GMP inspection application dossiers<\/li>\n
    • Preparation of Type I and Type II variation application dossiers in accordance with current legal requirements and guidelines<\/li>\n<\/ul>\n

      [\/vc_column_text][\/vc_column][\/vc_row][vc_row el_id=”tibbi-cihazlar”][vc_column][vc_custom_heading text=”Medical Devices” font_container=”tag:h3|text_align:left” use_theme_fonts=”yes”]

      [vc_separator color=”custom” align=”align_left” border_width=”3″ el_width=”10″ style=”solid” accent_color=”#00acb7″ css=”.vc_custom_1672651401340{margin-top: -20px !important;}”]<\/div>[vc_column_text]<\/p>\n
        \n
      • Registration of manufacturer and importer company<\/li>\n
      • Evaluation of declarations of conformity and EC certificates for eligibility<\/li>\n
      • Registration of required class-specific documents<\/li>\n
      • Preparation of the initial approval application for registration in UTS (Product Tracking System), and submission electronically<\/li>\n
      • Preparation and submission electronically of update applications for post-approval changes in the manufacturer or the product,<\/li>\n
      • Preparation and submission electronically of withdrawal applications<\/li>\n
      • Preparation of product catalogues<\/li>\n
      • Evaluation of labels, texts and artwork before launch for compliance with current legal requirements<\/li>\n<\/ul>\n

        [\/vc_column_text][\/vc_column][\/vc_row][vc_row el_id=”kozmetik-urunler”][vc_column][vc_custom_heading text=”Cosmetics” font_container=”tag:h3|text_align:left” use_theme_fonts=”yes”]

        [vc_separator color=”custom” align=”align_left” border_width=”3″ el_width=”10″ style=”solid” accent_color=”#00acb7″ css=”.vc_custom_1672651409020{margin-top: -20px !important;}”]<\/div>[vc_column_text]<\/p>\n
          \n
        • Registration of companies<\/li>\n
        • Registration of qualified persons<\/li>\n
        • Preparation and submission electronically of the initial approval application for registration in UTS (Product Tracking System)<\/li>\n
        • Preparation and submission electronically of update applications for post-approval changes in the manufacturer or the product<\/li>\n
        • Preparation of the Cosmetic Safety Assessment Report<\/li>\n
        • Preparation of the Product Information Dossier<\/li>\n
        • Evaluation of labels, texts and artwork before launch for compliance with current legal requirements<\/li>\n<\/ul>\n

          [\/vc_column_text][\/vc_column][\/vc_row][vc_row el_id=”takviye-edici-gidalar”][vc_column][vc_custom_heading text=”Food Supplements (FSs)” font_container=”tag:h3|text_align:left” use_theme_fonts=”yes”]

          [vc_separator color=”custom” align=”align_left” border_width=”3″ el_width=”10″ style=”solid” accent_color=”#00acb7″ css=”.vc_custom_1672651417284{margin-top: -20px !important;}”]<\/div>[vc_column_text]<\/p>\n
            \n
          • Registration of manufacturer and importer companies<\/li>\n
          • Preparation of approval application dossiers for imported or locally manufactured FSs<\/li>\n
          • Preparation of the control certificate application dossier for FSs that subject to control certificate.<\/li>\n
          • Evaluation of labels, texts and artwork before launch for in accordance with current legal requirements<\/li>\n
          • Preparation of GGBS pre-notification and shipment notification submissions for post-approval market launch of imported FSs<\/li>\n
          • Preparation of physical inspection dossiers<\/li>\n
          • Preparation of Ministry Commission application dossiers for unlisted ingredients<\/li>\n
          • Evaluation of the compliance of ingredients prepared for formulation development with the regulations<\/li>\n<\/ul>\n

            [\/vc_column_text][\/vc_column][\/vc_row][vc_row el_id=”biyosidal-urunler”][vc_column][vc_custom_heading text=”Biocidals” font_container=”tag:h3|text_align:left” use_theme_fonts=”yes”]

            [vc_separator color=”custom” align=”align_left” border_width=”3″ el_width=”10″ style=”solid” accent_color=”#00acb7″ css=”.vc_custom_1672651424316{margin-top: -20px !important;}”]<\/div>[vc_column_text]<\/p>\n
              \n
            • Preparation of application dossiers for Type I and Type 19 biocidal products<\/li>\n<\/ul>\n

              [\/vc_column_text][\/vc_column][\/vc_row][vc_row el_id=”guvenlik-bilgi-formu-hazirlanmasi”][vc_column][vc_custom_heading text=”Safety Data Sheet (SDS) Preparation” font_container=”tag:h3|text_align:left” use_theme_fonts=”yes”]

              [vc_separator color=”custom” align=”align_left” border_width=”3″ el_width=”10″ style=”solid” accent_color=”#00acb7″ css=”.vc_custom_1672651432044{margin-top: -20px !important;}”]<\/div>[\/vc_column][\/vc_row][vc_row el_id=”diger”][vc_column][vc_custom_heading text=”Other” font_container=”tag:h3|text_align:left” use_theme_fonts=”yes”]
              [vc_separator color=”custom” align=”align_left” border_width=”3″ el_width=”10″ style=”solid” accent_color=”#00acb7″ css=”.vc_custom_1672651438516{margin-top: -20px !important;}”]<\/div>[vc_column_text]<\/p>\n
                \n
              • Preparation of required application dossiers for Compassionate Use Programs<\/li>\n
              • Preparation of application dossiers for Programs for Post-Clinical Trial Access to Medicine<\/li>\n
              • Providing Due Diligence services<\/li>\n<\/ul>\n

                [\/vc_column_text][\/vc_column][\/vc_row]<\/p>\n","protected":false},"excerpt":{"rendered":"

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