{"id":163,"date":"2024-04-19T16:39:56","date_gmt":"2024-04-19T07:39:56","guid":{"rendered":"https:\/\/cm-plus.co.jp\/en\/?page_id=163"},"modified":"2024-08-08T12:07:33","modified_gmt":"2024-08-08T03:07:33","slug":"regulatory_affairs","status":"publish","type":"page","link":"https:\/\/cm-plus.co.jp\/en\/service\/consulting\/regulatory_affairs\/","title":{"rendered":"Regulatory Affairs Consulting"},"content":{"rendered":"<div id=\"regulatory_affairs\">\n<div id=\"pagePath\">\n<ul>\n<li><a href=\"https:\/\/cm-plus.co.jp\/en\/\">Home<\/a>\/<\/li>\n<li><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/\">Services<\/a>\/<\/li>\n<li><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/consulting\/\">Consulting<\/a>\/<\/li>\n<li>Regulatory Affairs Consulting<\/li>\n<\/ul>\n<\/div>\n<div class=\"h1Sub\">\n<div class=\"content\">\n<h1 class=\"h1Ttl\"><span class=\"subSpan\">Consulting<\/span><br class=\"wpTag\">Regulatory Affairs Consulting<br \/>\n<span class=\"h1Photo\"><br \/>\n<span class=\"maskBox\"><br \/>\n<span class=\"topCover\"><br \/>\n<img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/common\/key01.webp\" alt=\"Consulting Regulatory Affairs Consulting\"><br \/>\n<\/span><br \/>\n<span class=\"btmImg01\"><br \/>\n<img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/common\/image-service11.webp\" alt=\"Consulting Regulatory Affairs Consulting\"><br \/>\n<\/span><br \/>\n<span class=\"btmImg02\"><br \/>\n<img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/common\/image-service11.webp\" alt=\"Consulting Regulatory Affairs Consulting\"><br \/>\n<\/span><br \/>\n<\/span><br \/>\n<\/span><br \/>\n<\/h1>\n<\/div>\n<\/div>\n<div class=\"content\">\n<div class=\"mainBox\">\n<article id=\"conts\">\n<section class=\"sec01 secBox\">\n<h2 class=\"headLine05\">Pharmaceutical life cycle and task at each step<\/h2>\n<p class=\"comTxt\">Each step in the pharmaceutical life cycle involves the following tasks:<\/p>\n<div class=\"biPhoto\">\n<img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/service\/gmp_consulting\/regulatory_affairs\/photo01.webp\" alt=\"Pharmaceutical life cycle and task at each step\"><br \/>\n<span class=\"photoIco\"><br \/>\n<a href=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/service\/gmp_consulting\/regulatory_affairs\/photo01.webp\" class=\"popImg\">&nbsp;<\/a><br \/>\n<\/span>\n<\/div>\n<ul class=\"comTextList\">\n<li>* The red underline indicates the scope of CM Plus&#8217;s regulatory consulting service.<\/li>\n<\/ul>\n<\/section>\n<section class=\"sec02 secBox\">\n<h2 class=\"headLine05\">Pharmaceutical Regulatory Affairs Consulting from CM Plus<\/h2>\n<p class=\"comTxt\">Our experts offer pharmaceutical regulatory affairs consulting services with <strong>abundant practical experience<\/strong> of the industry to meet our customers&#8217; needs.<\/p>\n<ul class=\"comRaiList\">\n<li>Regulatory Application Strategy<\/li>\n<li>Building Internal Systems such as GQP \/ GVP<\/li>\n<li>Various Consultations with the Pharmaceuticals and Medical Devices Agency (PMDA)<\/li>\n<li>Support for Manufacturing\/Marketing Business License for Pharmaceutical Products etc.\/ Manufacturing Business License\/ Application for Accreditation of Foreign Manufacturers (including Support for Inquiry Response) <\/li>\n<li>Business Support for Creating Approval Application Forms and Application Materials<\/li>\n<li>Business Support for Partial Change, minor change (including support for inquiry response) <\/li>\n<\/ul>\n<\/section>\n<section class=\"sec03 secBox\">\n<h2 class=\"headLine05\">Customer\u2019s Benefits from CM Plus Pharmaceutical Regulatory Affairs Consulting<\/h2>\n<div class=\"comExplainBox pink\">\n<h3 class=\"headLine06\"><span class=\"num barlow\">1.<\/span><span class=\"wpTag\"> Regulatory Affairs Consulting Services at all stages, from Development to Post-Marketing<\/span><\/h3>\n<p class=\"wpTag\">CM Plus provides consulting services for regulatory affairs development, CMC regulatory affairs, and pharmaceutical regulatory affairs <strong>at all stages, from the development stage, approval application, manufacturing, to post-marketing.<\/strong> We can handle new drugs, generic drugs, long-listed drugs (after the re-examination period), and various types of drugs.<\/p>\n<\/div>\n<div class=\"comExplainBox pink\">\n<h3 class=\"headLine06\"><span class=\"num barlow\">2.<\/span><span class=\"wpTag\">Regulatory Affairs Consulting Services in <span class=\"red\">Collaboration with GMP Consulting Services.<\/span><\/span><\/h3>\n<p class=\"wpTag\">CM Plus provides two services. The first is &#8220;GMP consulting services, from the perspective of GMP manufacturing and QA quality assurance department&#8221; (on-site support). The second is &#8220;pharmaceutical regulatory affairs consulting services, from the perspective of regulatory interpretation and document procedures&#8221; (we provide consulting service of regulatory response to regulatory authorities, from application to inquiry response). Combining these two services enables us to provide <strong>collaborative GMP, QA, and regulatory consulting services that are more suitable for the site<\/strong>.<\/p>\n<\/div>\n<div class=\"biPhoto\">\n<img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/service\/gmp_consulting\/regulatory_affairs\/photo02.webp\" alt=\"Customer\u2019s Benefits from CM Plus Pharmaceutical Regulatory Affairs Consulting\"><br \/>\n<span class=\"photoIco\"><br \/>\n<a href=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/service\/gmp_consulting\/regulatory_affairs\/photo02.webp\" class=\"popImg\">&nbsp;<\/a><br \/>\n<\/span>\n<\/div>\n<\/section>\n<section class=\"sec04 secBox\">\n<h2 class=\"headLine05\">Designated Marketing Authorization Holder <br class=\"wpTag\">and In-Country Clinical Caretaker<\/h2>\n<p class=\"comTxt\">CM Plus has obtained the first-class and second-class marketing licenses for drug. We can be appointed as <strong>Designated Marketing Authorization Holder (D-MAH)<\/strong> for companies that have no company established in Japan. We also provide services any support for clinical trials in Japan that conform to Japan GCP Ministerial Ordinance as <strong>In-Country Clinical Caretaker (ICCC: Article 15 in GCP Ministerial Ordinance) (sponsor role in Japan)<\/strong> <\/p>\n<div class=\"biPhoto\">\n<img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/service\/gmp_consulting\/regulatory_affairs\/photo03.webp\" alt=\"Designated Marketing Authorization Holder and In-Country Clinical Caretaker\"><br \/>\n<span class=\"photoIco\"><br \/>\n<a href=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/service\/gmp_consulting\/regulatory_affairs\/photo03.webp\" class=\"popImg\">&nbsp;<\/a><br \/>\n<\/span>\n<\/div>\n<h3 class=\"headLine06\">Designated Marketing Authorization Holder (D-MAH) Service<\/h3>\n<p class=\"comTxt comTxt01\">This service enables foreign manufacturers to enter the Japanese market for pharmaceutical products voluntarily.<\/p>\n<div class=\"comImgBox\">\n<div class=\"photoBox\">\n<div class=\"biPhoto\">\n<img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/service\/gmp_consulting\/regulatory_affairs\/photo04.webp\" alt=\"Designated Marketing Authorization Holder (D-MAH) Service\"><br \/>\n<span class=\"photoIco\"><br \/>\n<a href=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/service\/gmp_consulting\/regulatory_affairs\/photo04.webp\" class=\"popImg\">&nbsp;<\/a><br \/>\n<\/span>\n<\/div>\n<\/div>\n<div class=\"textBox\">\n<p class=\"wpTag\">In the case that a foreign manufacturer does not have a base for business operations in Japan for the sales of pharmaceuticals and medical devices, it is necessary to appoint one manufacturing\/marketing business license holder in Japan.<\/p>\n<p class=\"wpTag\"> CM Plus has obtained the first-class and second-class marketing licenses for pharmaceuticals. We will provide services as a Designated Marketing Authorization Holder (D-MAH) for foreign manufacturers who have entered the Japanese market and consider importing and selling.<\/p>\n<\/div>\n<\/div>\n<h3 class=\"headLine06\">In-Country Clinical Caretaker (ICCC) Service<\/h3>\n<p class=\"comTxt comTxt01\">This service enables clinical trials to be conducted in Japan on behalf of overseas pharmaceutical companies (pharmaceutical companies, drug discovery ventures, etc.) without a legal entity.<\/p>\n<div class=\"comImgBox\">\n<div class=\"photoBox photoBox01\">\n<div class=\"biPhoto\">\n<img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/service\/gmp_consulting\/regulatory_affairs\/photo05.webp\" alt=\"In-Country Clinical Caretaker (ICCC) Service\"><br \/>\n<span class=\"photoIco\"><br \/>\n<a href=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/service\/gmp_consulting\/regulatory_affairs\/photo05.webp\" class=\"popImg\">&nbsp;<\/a><br \/>\n<\/span>\n<\/div>\n<\/div>\n<div class=\"textBox\">\n<p class=\"wpTag\">When a company without a legal entity in Japan conducts a clinical trial in Japan, it is necessary to prevent the occurrence or spread of health hazards caused by the investigational drug. It is required to appoint a person addressed in Japan as a person who can request a clinical trial on behalf of the person.<\/p>\n<p class=\"wpTag\"> As a clinical development partner, CM Plus will play the sponsor role in Japan (ICCC: Article 15 in GCP Ministerial Ordinance) on behalf of a pharmaceutical company without a business base in Japan.<\/p>\n<\/div>\n<\/div>\n<\/section>\n<section class=\"sec05 secBox comBorBox\">\n<h2 class=\"headLine05\">Do you have following problems?<\/h2>\n<h3 class=\"headLine06\">For Overseas Companies<\/h3>\n<div class=\"comTalkBox\">\n<div class=\"area\">\n<div class=\"peo\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/common\/com_peo01.webp\" alt=\"For Overseas Companies\"><\/div>\n<div class=\"txtBox\">\n<p class=\"txt01\"><strong>Even if We have no business base company in Japan, can We obtain Manufacturing\/ marketing approval of pharmaceutical products without out-licensing the product?<\/strong><\/p>\n<\/div>\n<\/div>\n<div class=\"arrow\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/common\/arrow04.webp\" alt=\"\"><\/div>\n<div class=\"area pink\">\n<div class=\"peo\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/common\/com_peo02.webp\" alt=\"For Overseas Companies\"><\/div>\n<div class=\"txtBox\">\n<p class=\"wpTag\">CM Plus has obtained business licenses for the first-class and second-class marketing licenses for pharmaceuticals. <strong>Appointing CM Plus as the Designated Marketing Authorization Holder (D-MAH) makes it possible to apply for foreign special approval.<\/strong> You can use it to apply for Marketing approval in Japan.<\/p>\n<\/div>\n<\/div>\n<div class=\"area\">\n<div class=\"peo\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/common\/com_peo03.webp\" alt=\"For Overseas Companies\"><\/div>\n<div class=\"txtBox\">\n<p class=\"wpTag\"><strong>Is it possible to conduct a clinical trial in Japan even if there is no company based in Japan?<\/strong><\/p>\n<\/div>\n<\/div>\n<div class=\"arrow\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/common\/arrow04.webp\" alt=\"\"><\/div>\n<div class=\"area pink\">\n<div class=\"peo\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/common\/com_peo02.webp\" alt=\"For Overseas Companies\"><\/div>\n<div class=\"txtBox\">\n<p class=\"wpTag\"><strong>By appointing CM Plus as the In-Country Clinical Caretaker (ICCC), clinical trials can be conducted in Japan as needed.<\/strong> Also, we have staff with abundant experience in development and marketing, and CMP can propose a clinical trial implementation system (CRO, medical institution, testing institution) in Japan.<\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/section>\n<section class=\"comBorBox comBorBox02\">\n<h2 class=\"headLine04\">Related Contents<\/h2>\n<ul class=\"comLinkList\">\n<li><a href=\"https:\/\/cm-plus.co.jp\/en\/portfolio\/project_details\/\">\n<div class=\"photo\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/common\/photo05.webp\" alt=\"Projects\"><\/div>\n<p><span class=\"subSpan\">Projects<\/span><br \/>\n<\/a><\/li>\n<li><a href=\"https:\/\/cm-plus.co.jp\/en\/about_cm_plus\/record\/\">\n<div class=\"photo\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/common\/photo06.webp\" alt=\"Performance by Numbers\"><\/div>\n<p><span class=\"subSpan\">Performance by Numbers<\/span><br \/>\n<\/a><\/li>\n<\/ul>\n<\/section>\n<section>\n<h2 class=\"headLine04\">Other Services<\/h2>\n<ul class=\"comLinkList\">\n<li><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/engineering\/\"><br \/>\n<span class=\"photo\"><img decoding=\"async\" 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scope of CM Plus&#8217;s regulatory consulting service. Pharmaceutical Regulatory Affairs Consulting from CM Plus Our experts offer pharmaceutical regulatory affairs consulting services with abundant practical experience of the industry to meet our customers&#8217; needs. Regulatory Application Strategy Building Internal Systems such as GQP \/ GVP Various Consultations with the Pharmaceuticals and Medical Devices Agency (PMDA) Support for Manufacturing\/Marketing Business License for Pharmaceutical Products etc.\/ Manufacturing Business License\/ Application for Accreditation of Foreign Manufacturers (including Support [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":155,"menu_order":53,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":""},"keywords":[11],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v22.4 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Regulatory Affairs Consulting\uff5cCM Plus<\/title>\n<meta name=\"description\" content=\"Experienced consultants in regulatory affairs support you with services tailored to your specific challenges.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, 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