{"id":599,"date":"2023-11-23T19:36:15","date_gmt":"2023-11-23T19:36:15","guid":{"rendered":"https:\/\/raifarm.com.cn\/en\/?page_id=599"},"modified":"2023-12-06T13:30:40","modified_gmt":"2023-12-06T13:30:40","slug":"drug-registration-services","status":"publish","type":"page","link":"https:\/\/raifarm.com.cn\/en\/drug-registration-services\/","title":{"rendered":"Drug registration services in Russia and EAEU"},"content":{"rendered":"

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Drug Registration Services in Russia and EAEU<\/h1>\n

[\/et_pb_text][et_pb_divider color=”#4fade0″ divider_weight=”3px” _builder_version=”4.23.1″ _module_preset=”default” width=”10%” custom_margin=”-20px||||false|false” locked=”off” global_colors_info=”{}”][\/et_pb_divider][\/et_pb_column][et_pb_column type=”3_5″ _builder_version=”4.23.1″ _module_preset=”default” global_colors_info=”{}”][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ use_custom_gutter=”on” gutter_width=”2″ specialty=”on” _builder_version=”4.23.1″ _module_preset=”default” inner_width=”95%” inner_max_width=”100%” custom_padding=”0px||0px|||” global_colors_info=”{}”][et_pb_column type=”1_4″ _builder_version=”4.16″ custom_padding=”|||” global_colors_info=”{}” custom_padding__hover=”|||”][et_pb_text disabled_on=”on|on|off” _builder_version=”4.23.1″ _module_preset=”default” header_4_font=”|700|||||||” header_4_font_size=”20px” header_4_line_height=”1.5em” text_orientation=”center” width=”90%” module_alignment=”center” custom_padding=”30px|15px|30px|15px|true|true” sticky_position=”top” sticky_limit_bottom=”section” border_width_all=”1px” border_color_all=”#e5e5e5″ global_module=”672″ saved_tabs=”all” global_colors_info=”{}”]<\/p>\n

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Need a consultation?<\/h4>\n

Our experts will answer any question of interest<\/p>\n

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[\/et_pb_text][\/et_pb_column][et_pb_column type=”3_4″ specialty_columns=”3″ _builder_version=”4.16″ custom_padding=”|||” global_colors_info=”{}” custom_padding__hover=”|||”][et_pb_row_inner column_structure=”1_2,1_2″ use_custom_gutter=”on” gutter_width=”2″ make_equal=”on” _builder_version=”4.23.1″ _module_preset=”default” custom_margin=”40px||||false|false” custom_padding=”0px||0px|||” global_colors_info=”{}”][et_pb_column_inner type=”1_2″ saved_specialty_column_type=”3_4″ _builder_version=”4.23.1″ _module_preset=”default” custom_css_main_element=”width:40% !important;” global_colors_info=”{}” custom_css_main_element_last_edited=”on|phone” custom_css_main_element_tablet=”width:auto;” custom_css_main_element_phone=”width:auto;”][et_pb_image src=”https:\/\/raifarm.com.cn\/en\/wp-content\/uploads\/sites\/2\/2023\/11\/baner1-1.webp” title_text=”baner1″ _builder_version=”4.23.1″ _module_preset=”default” border_radii=”on|5px|5px|5px|5px” global_colors_info=”{}”][\/et_pb_image][\/et_pb_column_inner][et_pb_column_inner type=”1_2″ saved_specialty_column_type=”3_4″ _builder_version=”4.23.1″ _module_preset=”default” global_colors_info=”{}”][et_pb_text ul_type=”square” ul_item_indent=”5%” _builder_version=”4.23.1″ _module_preset=”default” text_font_size=”18px” text_line_height=”1.8em” ul_text_color=”#4fade0″ ul_font_size=”18px” ul_line_height=”1.8em” header_2_font=”|700|||||||” header_2_font_size=”35px” header_2_line_height=”1.5em” header_3_font=”|700|||||||” header_3_font_size=”35px” header_3_line_height=”1.5em” global_colors_info=”{}”]Secure commercial rights for pharmaceutical products in Russia, in compliance with the standards and regulations of the Eurasian Economic Union (EAEU).<\/strong>[\/et_pb_text][\/et_pb_column_inner][\/et_pb_row_inner][et_pb_row_inner _builder_version=”4.23.1″ _module_preset=”default” custom_padding=”||0px|||” global_colors_info=”{}”][et_pb_column_inner saved_specialty_column_type=”3_4″ _builder_version=”4.23.1″ _module_preset=”default” global_colors_info=”{}”][et_pb_text ul_type=”square” ul_item_indent=”5%” _builder_version=”4.23.1″ _module_preset=”default” ul_text_color=”#4fade0″ ul_font_size=”15px” ul_line_height=”1.8em” header_2_font=”|700|||||||” header_2_font_size=”35px” header_2_line_height=”1.5em” header_3_font=”|700|||||||” header_3_font_size=”30px” header_3_line_height=”1.5em” custom_margin=”||18px|||” global_colors_info=”{}”]<\/p>\n

Realizing Potential Through Expert Regulatory Guidance<\/h3>\n

With over 150 healthcare product approvals across Russia and the Eurasian Economic Union (EAEU), Raifarm offers over a decade of specialized expertise to strategically steer innovations through complex registration and compliance processes. Our accomplished team has facilitated hundreds of successful submissions across diverse therapeutic areas.<\/p>\n

Strategic Insights to Accelerate Russian\/EAEU Access Leveraging extensive in-country and regional experience, we provide keen guidance identifying the most viable regulatory pathways aligned to your commercialization objectives across target markets. Our consultants anticipate hurdles and swiftly adapt dossiers and messaging.<\/p>\n

Hands-On Dossier Management<\/h3>\n

We meticulously compile Russian and EAEU registration packages, proactively manage review processes, address queries, check final formats, and help clients fully own submissions. For post-approval compliance, we oversee modifications, renewals, risk management, variations and more.<\/p>\n

Ongoing Excellence Through Training<\/h3>\n

Dedicated to excellence, Raifarm directs continual advancement programs equipping our specialists by collaborating cross-functionally to incorporate the latest Russian and EAEU regulatory developments.<\/p>\n

Technology Safeguards<\/h3>\n

Leveraging robust systems, we secure regulatory information against vulnerabilities while unlocking actionable insights from data patterns. Our tech-enabled quality checks further prevent oversights.<\/p>\n

With patient well-being at the forefront, our vision is to expand access to meaningful healthcare innovations by guiding products efficiently through key market registrations and compliances. As your vested partners, we focus singly on achieving approvals and post-authorization success.<\/p>\n

Raifarm Regulatory Registration Services<\/h3>\n
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  • Consultation and Submission Guidance Provide strategic advice and direction on product registration procedures, managing local trials, dossier modifications, renewals, and developing optimized submission approaches for Russia and the Eurasian Economic Union (EAEU).<\/span><\/li>\n
  • Dossier Preparation and Compliance Meticulously compile registration packages, confirm adherence to the latest norms, and prepare administrative documentation for submission to governing health authorities.<\/span><\/li>\n
  • Technical and Quality Document Authoring<\/span><\/li>\n
  • Collaborate with clients to generate required regulatory materials encompassing manufacturing procedures, quality control methods, packaging, drug instructions, import\/export administration, and more.<\/span><\/li>\n
  • Expertly navigating regulatory inquiries, interpreting feedback, and formulating responses for clients to accelerate review processes and approval decisions.<\/span><\/li>\n
  • Manage the translation and notarization of essential registration documents with precision and efficiency.<\/span><\/li>\n<\/ul>\n

    With a commitment to quality, expertise in regional regulations, and dedicated client focus, Raifarm completes the end-to-end management of registrations efficiently. Our integrated capabilities encompass planning, trials, compilation, submission, follow-ups, and approval across Russia and the EAEU.<\/p>\n

    Drug Registration Services Costs and Pricing:<\/span><\/h3>\n

    [\/et_pb_text][et_pb_text _builder_version=”4.23.1″ _module_preset=”default” text_font_size=”18px” text_line_height=”1.8em” hover_enabled=”0″ global_colors_info=”{}” sticky_enabled=”0″]<\/p>\n

    \n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
    Raifarm service fee<\/span><\/strong><\/span>\uff08russian rubles\uff091<\/sup><\/span> <\/strong><\/span><\/td>\n<\/tr>\n
    Service<\/strong><\/span><\/td>\nTerm (months)<\/span>5<\/sup><\/strong><\/span><\/td>\nmin<\/span><\/strong><\/td>\nmax<\/strong><\/span><\/td>\n<\/tr>\n
    Fixed service fees (milestones based)\u00a0<\/span>2<\/sup><\/b><\/td>\n<\/td>\n\u00a0<\/span><\/td>\n\u00a0<\/span><\/td>\n<\/tr>\n
    Drug registration in Russia as the Referent State of EAEU3-4<\/sup><\/strong><\/span><\/td>\n15-184<\/sup><\/strong><\/span><\/td>\n3900000<\/span><\/td>\n6900000<\/span><\/td>\n<\/tr>\n
    The consequent recognition of the drug in one of the Confirmation State of EAEU<\/span><\/td>\n6-10<\/span><\/td>\n350000<\/td>\n900000<\/td>\n<\/tr>\n
    National RB or RK dossier alignment with EAEU requirements and the following geography extension to Russia<\/span><\/td>\n10-12<\/td>\n2900000<\/td>\n3900000<\/td>\n<\/tr>\n
    National RF dossier alignment with EAEU requirements<\/span><\/td>\n10-12<\/td>\n1900000<\/td>\n3500000<\/td>\n<\/tr>\n
    Readability test of patient information leaflet<\/span><\/td>\n2-3<\/td>\n600000<\/td>\n900000<\/td>\n<\/tr>\n
    CMC variation with expert evaluation requiring laboratory examination<\/span><\/td>\n3-157<\/sup><\/strong><\/span><\/td>\n900000<\/td>\n1500000<\/td>\n<\/tr>\n
    CMC variation with expert evaluation not requiring laboratory examination<\/span><\/td>\n3-157<\/sup><\/strong><\/span><\/td>\n200000<\/td>\n800000<\/td>\n<\/tr>\n
    Variation requiring evaluation of safety-efficacy ratio<\/span><\/td>\n3-157<\/sup><\/strong><\/span><\/td>\n500000<\/td>\n900000<\/td>\n<\/tr>\n
    Administrative variation not requiring expert evaluation<\/span><\/td>\n3-157<\/sup><\/strong><\/span><\/td>\n150000<\/td>\n350000<\/td>\n<\/tr>\n
    Gap analysis of the registration dossier to assess strategy of registration in EAEU<\/span><\/td>\n<\/td>\n200000<\/td>\n400000<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n