{"id":113,"date":"2025-07-08T12:04:28","date_gmt":"2025-07-08T10:04:28","guid":{"rendered":"https:\/\/pharmconsult.com.pl\/?page_id=113"},"modified":"2025-09-18T15:19:32","modified_gmt":"2025-09-18T13:19:32","slug":"oferta","status":"publish","type":"page","link":"https:\/\/pharmconsult.com.pl\/en\/oferta\/","title":{"rendered":"Offer"},"content":{"rendered":"
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An offer tailored to your needs<\/h2>\t\t\t\t<\/div>\n\t\t\t\t
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Comprehensive registration services, regulatory affairs, and pharmacovigilance \u2013 we support pharmaceutical companies in effectively bringing products to market.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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Regulatory affairs<\/h2>\t\t\t\t<\/div>\n\t\t\t\t
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Our regulatory affairs services for medicinal products cover the following regulatory activities:<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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Medicinal Products Registration<\/h2>\t\t\t\t<\/div>\n\t\t\t\t
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Our offer includes activities related to the registration of medicinal products in Poland and European Union countries within the framework of:<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t

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  • \n\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t<\/stop><\/stop><\/radialgradient><\/defs><\/circle><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\tNational procedures\u00a0\u00a0<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t
  • \n\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t<\/stop><\/stop><\/radialgradient><\/defs><\/circle><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\tEuropean procedures (Mutual Recognition Procedure \u2013 MRP, Decentralised Procedure \u2013 DCP, and support in the Centralised Procedure), covering both full procedure management and coordination as well as support limited to national phases only.<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t<\/ul>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t
    \n\t\t\t\t\t\t\t\t\tPreparation and translation of product information documents (Summary of Product Characteristics, Patient Leaflet, packaging labelling) including Braille.

    \nCoordination of leaflet readability testing (PIL readability testing, PIL user testing) in accordance with current EU and European agency guidelines.

    \nPreparation of registration documentation and substantive evaluation of documentation regarding future registration, product category, available studies, anticipated questions from the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPLWMiPB), and possible solutions to avoid additional, complex questions that significantly increase costs and extend the registration process.

    \nPreparation of expert reports, overall Quality Overview Summary (QOS), and preparation of Modules 4 and 5 for Well Established Use (WEU) products.

    \nPreparation of responses to procedural questions from URPLWMiPB as well as substantive questions related to documentation, studies, or dossier content.\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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    Post-authorization variations and notifications<\/h2>\t\t\t\t<\/div>\n\t\t\t\t
    \n\t\t\t\t\t\t\t\t\tWe provide support related to maintenance of marketing authorization, including post-authorization variations, and notifications within all registration procedures.

    \nWe support implementation of changes in product information and printed materials.\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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    Renewals<\/h2>\t\t\t\t<\/div>\n\t\t\t\t
    \n\t\t\t\t\t\t\t\t\tPreparation of the renewal application

    \nVerification of the dossier for possible necessary post-authorization variations before submission

    \nPreparation of annexes and accompanying documentation for the application\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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    Medical Devices and Food Supplements<\/h2>\t\t\t\t<\/div>\n\t\t\t\t
    \n\t\t\t\t\t\t\t\t\tWe offer comprehensive registration services for dietary supplements including:\n
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    • Expert assessment of your product\u2019s eligibility as a dietary supplement<\/li>\n \t
    • Professional preparation of packaging labelling that meets regulatory standards<\/li>\n \t
    • Coordination of scientific opinions, when needed<\/li>\n \t
    • Efficient notification to the Chief Sanitary Inspectorate (GIS)<\/li>\n \t
    • Registration of medical devices with URPLWMiPB<\/li>\n<\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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      Documentation audits<\/h2>\t\t\t\t<\/div>\n\t\t\t\t
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      We offer comprehensive audits of registration documentation including:<\/p>

      • Comprehensive verification of data accuracy and completeness within the registration dossier<\/li>
      • Preparation of a structured, regulator-ready audit report<\/li>
      • Assessment of the current regulatory status of your product<\/li>
      • Strategic advice on selecting the most appropriate registration pathway<\/li>
      • Risk evaluation tailored to your product\u2019s specific registration context<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>","protected":false},"excerpt":{"rendered":"

        Oferta dopasowana do Twoich potrzeb Kompleksowa obs\u0142uga rejestracyjna, regulatory affairs i pharmacovigilance \u2013 wspieramy firmy farmaceutyczne w skutecznym wprowadzaniu produkt\u00f3w na rynek. Regulatory affairs Oferta regulatory affairs dotycz\u0105ca produkt\u00f3w leczniczych obejmuje nast\u0119puj\u0105ce obszary dzia\u0142a\u0144 regulacyjnych: Rejestracja produkt\u00f3w leczniczych: Oferta obejmuje dzia\u0142ania w zakresie rejestracji produkt\u00f3w leczniczych w Polsce oraz w krajach Unii Europejskiej w ramach: […]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"elementor_header_footer","meta":{"footnotes":""},"class_list":["post-113","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/pharmconsult.com.pl\/en\/wp-json\/wp\/v2\/pages\/113","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/pharmconsult.com.pl\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/pharmconsult.com.pl\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/pharmconsult.com.pl\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/pharmconsult.com.pl\/en\/wp-json\/wp\/v2\/comments?post=113"}],"version-history":[{"count":160,"href":"https:\/\/pharmconsult.com.pl\/en\/wp-json\/wp\/v2\/pages\/113\/revisions"}],"predecessor-version":[{"id":493,"href":"https:\/\/pharmconsult.com.pl\/en\/wp-json\/wp\/v2\/pages\/113\/revisions\/493"}],"wp:attachment":[{"href":"https:\/\/pharmconsult.com.pl\/en\/wp-json\/wp\/v2\/media?parent=113"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}