{"id":169,"date":"2024-04-19T16:40:53","date_gmt":"2024-04-19T07:40:53","guid":{"rendered":"https:\/\/cm-plus.co.jp\/en\/?page_id=169"},"modified":"2024-08-08T14:21:42","modified_gmt":"2024-08-08T05:21:42","slug":"regenerative_medicine","status":"publish","type":"page","link":"https:\/\/cm-plus.co.jp\/en\/service\/consulting\/regenerative_medicine\/","title":{"rendered":"Regenerative Medicine Consulting"},"content":{"rendered":"<div id=\"regenerative_medicine\">\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>Regenerative Medicine 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\">Regenerative Medicine 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 Regenerative Medicine 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-consulting.webp\" alt=\"Consulting Regenerative Medicine 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-consulting.webp\" alt=\"Consulting Regenerative Medicine 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=\"secBox\">\n<h2 class=\"headLine05\">What is a regenerative medicine products?<br class=\"wpTag\">Classification under the Pharmaceutical and Medical Device Act<\/h2>\n<p class=\"comTxt\">A regenerative medicine product uses cells or genes for the treatment or prevention of diseases or injuries. The scope of regenerative medicine products defined under the Pharmaceutical and Medical Device Act (commonly known as the PMD Act) is as follows:<\/p>\n<ul class=\"comNumList\">\n<li><span class=\"num\">1.<\/span><span class=\"rSpan\">Products in which cells from humans or animals have been cultured or otherwise processed, with the purposes of:<br class=\"wpTag\">a. Reconstruction, repair, or formation of the structure or function of the body of humans or animals.<br class=\"wpTag\">b. Treatment or prevention of diseases in humans or animals.<\/span><\/li>\n<li><span class=\"num\">2.<\/span><span class=\"rSpan\">Products intended for the treatment of diseases in humans or animals that involve the introduction of genes into human or animal cells to express them in the body.<\/span><\/li>\n<\/ul>\n<div class=\"bigPhoto spPhoto smallPhoto\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/service\/gmp_consulting\/regenerative_medicine\/photo01.webp\" width=\"630\" alt=\"What is a regenerative medicine products?Classification under the Pharmaceutical and Medical Device Act\"><\/div>\n<p class=\"comTxt\">regenerative medicine products are classified separately from drugs and medical devices under the Pharmaceutical and Medical Device Act (commonly known as the PMD Act). Since regenerative medicine products involve the use of live cells or viruses themselves as products, specialized manufacturing and quality control different from those for drugs and medical devices are required.<\/p>\n<\/section>\n<section class=\"secBox\">\n<h2 class=\"headLine05\">Difference Between \u201cProducts\u201d and \u201cMedical Care\u201d in Regenerative Medicine<\/h2>\n<p class=\"comTxt\">In regenerative medicine, the applicable regulations differ depending on whether regenerative medicine products are provided by companies or medical care is offered within medical institutions. The former must comply with <span class=\"red\">the Pharmaceutical and Medical Device Act (PMD Act)<\/span> and adhere to the Good Gene, Cellular, and Tissue-based Products Manufacturing Practice (GCTP) ordinance, requiring appropriate manufacturing facilities and stringent manufacturing and quality control. On the other hand, the latter is subject to <span class=\"red\">theAct on Securing Safety of Regenerative Medicine<\/span>, under which clinical research or private medical practice must be conducted.<\/p>\n<div class=\"bigPhoto\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/service\/gmp_consulting\/regenerative_medicine\/photo02.webp\" width=\"840\" alt=\"Difference Between \u201cProducts\u201d and \u201cMedical Care\u201d in Regenerative Medicine\"><span class=\"photoIco\"><a href=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/service\/gmp_consulting\/regenerative_medicine\/photo02.webp\" class=\"popImg\">&nbsp;<\/a><\/span><\/div>\n<\/section>\n<section class=\"secBox\">\n<h2 class=\"headLine05\" id=\"a01\">CM Plus\u2019s Support for Regenerative Medicine Products<\/h2>\n<h3 class=\"headLine06\">Steps from Development to Manufacturing and Sales of regenerative medicine products, etc.<\/h3>\n<p class=\"comTxt\">CM Plus support our clients through every phase, from the basic research to post-marketing of regenerative medicine products, etc.<\/p>\n<div class=\"bigPhoto bigPhoto02\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/service\/gmp_consulting\/regenerative_medicine\/photo03.webp\" width=\"840\" alt=\"Steps from Development to Manufacturing and Sales of regenerative medicine products, etc.\"><span class=\"photoIco\"><a href=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/service\/gmp_consulting\/regenerative_medicine\/photo03.webp\" class=\"popImg\">&nbsp;<\/a><\/span><\/div>\n<div class=\"comWishBox\">\n<div class=\"area\">\n<h4 class=\"headLine06\">CM Plus can help you if you want to:<\/h4>\n<ul class=\"comCheckList\">\n<li>Consider entering the regenerative medicine industry from a different field.<\/li>\n<li>build an organization that complies with GCTP.<\/li>\n<li>scale up equipment from lab scale to commercial scale and need support for equipment selection and specification decisions.<\/li>\n<li>create documents that comply with the recent risk-based approach.<\/li>\n<li>advice on whether to own a CPC facility in-house or to outsource it.<\/li>\n<li>perform validations and create SOPs for production but lack internal resources.<\/li>\n<li>conduct a GAP analysis to check if your facilities meet the latest regulatory requirements.<\/li>\n<li>someone to accompany you for pre-consultations and inspections with regulatory authorities.<\/li>\n<li>rent a lab and install equipment, and need to plan a layout that complies with GCTP, etc.<\/li>\n<\/ul>\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<h3 class=\"headLine06\">What CM Plus Regenerative Medicine Consulting service can do<\/h3>\n<ul class=\"comCheckList red\">\n<li>CM Plus have consultants in various fields. In the field of regenerative medicine, we can provide one-stop solutions for your needs by integrating consulting and engineering services. Whether it\u2019s regulatory submission strategies in the research and development phase, GCTP organizational structures, or CPC facility planning in the manufacturing phase, we have the expertise to support you.<\/li>\n<\/ul>\n<\/div>\n<\/div>\n<h3 class=\"headLine06\">One-Stop Service for Regenerative Medicine by CM Plus<\/h3>\n<p class=\"comTxt\">Our highly experienced regenerative medicine consultants and engineers provide services tailored to your specific needs.<\/p>\n<div class=\"bigPhoto smallPhoto02\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/service\/gmp_consulting\/regenerative_medicine\/photo04.webp\" width=\"840\" alt=\"One-Stop Service for Regenerative Medicine by CM Plus\"><span class=\"photoIco\"><a href=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/service\/gmp_consulting\/regenerative_medicine\/photo04.webp\" class=\"popImg\">&nbsp;<\/a><\/span><\/div>\n<div class=\"imgBoxInner\">\n<div class=\"comImgBox\">\n<div class=\"photoBox\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/service\/gmp_consulting\/regenerative_medicine\/photo05.webp\" alt=\"QMS\/GCTP Consulting\"><\/div>\n<div class=\"textBox\">\n<h4 class=\"headLine10\">QMS\/GCTP Consulting<\/h4>\n<p class=\"wpTag\">-Support for building QMS and GCTP compliant organizations<br class=\"wpTag\">-GCTP education support<br class=\"wpTag\">-Supplier management support<br class=\"wpTag\">-GAP analysis and inspection support<\/p>\n<div class=\"comLinkP02\"><a href=\"https:\/\/cm-plus.co.jp\/en\/consultant_profiles\/#cat37\">Profiles of Regenerative Medicine Specialists<\/a><\/div>\n<div class=\"comLinkP02\"><a href=\"https:\/\/cm-plus.co.jp\/en\/consultant_profiles\/#cat21\">Profiles of GMP\/GCTP Consultants<\/a><\/div>\n<\/div>\n<\/div>\n<div class=\"comImgBox\">\n<div class=\"photoBox\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/service\/gmp_consulting\/regenerative_medicine\/photo06.webp\" alt=\"Regulatory Affairs Consulting\"><\/div>\n<div class=\"textBox\">\n<h4 class=\"headLine10\">Regulatory Affairs Consulting<\/h4>\n<p class=\"wpTag\">-Support for creating development plans<br class=\"wpTag\">-Support for various consultations with the Pharmaceuticals and Medical Devices Agency (PMDA)<br class=\"wpTag\">-Support for obtaining manufacturing and marketing authorizations\/manufacturer\u2019s licenses\/foreign manufacturer certifications (including responding to inquiries)<br class=\"wpTag\">-Preparation of approval applications and related documents<\/p>\n<div class=\"comLinkP02\"><a href=\"https:\/\/cm-plus.co.jp\/en\/consultant_profiles\/#cat28\">Profiles of Regulatory Affairs Consultants<\/a><\/div>\n<\/div>\n<\/div>\n<div class=\"comImgBox\">\n<div class=\"photoBox\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/service\/gmp_consulting\/regenerative_medicine\/photo07.webp\" alt=\"Facility and Equipment Diagnosis\/Construction Support\"><\/div>\n<div class=\"textBox\">\n<h4 class=\"headLine10\">Facility and Equipment Diagnosis\/Construction Support<\/h4>\n<p class=\"wpTag\">-Facility design support including basic plans and basic designs for GPC facility construction plans<br class=\"wpTag\">-Support for equipment selection and specification creation when introducing production equipment<br class=\"wpTag\">-Construction management during CPC facility construction<\/p>\n<div class=\"comLinkP02\"><a href=\"https:\/\/cm-plus.co.jp\/en\/consultant_profiles\/#cat33\">Profiles of Engineering Consultants<\/a><\/div>\n<\/div>\n<\/div>\n<div class=\"comImgBox\">\n<div class=\"photoBox\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/service\/gmp_consulting\/regenerative_medicine\/photo08.webp\" alt=\"Validation Support\"><\/div>\n<div class=\"textBox\">\n<h4 class=\"headLine10\">Validation Support<\/h4>\n<p class=\"wpTag\">-Support for creating validation documentation when introducing equipment<br class=\"wpTag\">-Creation of various SOPs<br class=\"wpTag\">-Validation management tasks<\/p>\n<div class=\"comLinkP02\"><a href=\"https:\/\/cm-plus.co.jp\/en\/consultant_profiles\/#cat36\">Profiles of Validation Consultants<\/a><\/div>\n<\/div>\n<\/div>\n<div class=\"comImgBox\">\n<div class=\"photoBox\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/service\/gmp_consulting\/regenerative_medicine\/photo09.webp\" alt=\"Foreign Language Support\"><\/div>\n<div class=\"textBox\">\n<h4 class=\"headLine10\">Foreign Language Support<\/h4>\n<p class=\"wpTag\">-Support for cross border factory construction projects<br class=\"wpTag\">-Support for obtaining foreign manufacturer certifications<br class=\"wpTag\">-Dispatch of interpreters for cross border inspections<br class=\"wpTag\">-Support for the preparation of English documentation<\/p>\n<div class=\"comLinkP02\"><a href=\"https:\/\/cm-plus.co.jp\/en\/consultant_profiles\/#cat29\">Profiles of International Business Consultants<\/a><\/div>\n<div class=\"comLinkP02\"><a href=\"https:\/\/cm-plus.co.jp\/en\/consultant_profiles\/#cat24\">Profiles of Interpreter and Translator Consultants<\/a><\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/section>\n<section class=\"secBox\">\n<h2 class=\"headLine05\">Example of Solving Your Concern \u2460<br class=\"wpTag\"><br \/>\n\t(For Regenerative Medicine Companies)<\/h2>\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=\"Example of Solving Your Concern \u2460(For Regenerative Medicine Companies)\"><\/div>\n<div class=\"txtBox\">\n<p class=\"wpTag\">We are starting a regenerative medicine business. We have a rough schedule, but we don\u2019t know where to start when it comes to obtaining marketing authorization, manufacturing and marketing licenses, GCTP compliance confirmation, and organizational structure building.<\/p>\n<\/div>\n<\/div>\n<p class=\"wpTag\">For cliants with such concerns, CM Plus can provide the following support:<\/p>\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=\"Drafting a Roadmap for Regenerative Medicine Business and Development Plans\"><\/div>\n<div class=\"txtBox\">\n<h3 class=\"headLine06\">Drafting a Roadmap for Regenerative Medicine Business and Development Plans<\/h3>\n<p class=\"wpTag\">When launching a regenerative medicine business, it is crucial to have a well-designed roadmap (master schedule) that comprehensively covers all necessary procedures and investigations in a carefully planned order. Creating this roadmap requires a high level of expertise and experience, making the involvement of experts with knowledge of regulatory affairs, QMS, and development experience in pharmaceuticals and regenerative medicine essential. CM Plus has many consultants specializing in the field of regenerative medicine, regulatory submissions, and QMS construction. We can support you in organizing each step\u2014from basic research, non-clinical trials, clinical trials, quality tests, marketing authorization, manufacturing and marketing licenses, GCTP compliance, and foreign manufacturer certifications\u2014and in drafting and planning your roadmap.<\/p>\n<div class=\"areaPhoto\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/service\/gmp_consulting\/regenerative_medicine\/photo10.webp\" alt=\"Drafting a Roadmap for Regenerative Medicine Business and Development Plans\" class=\"pc\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/service\/gmp_consulting\/regenerative_medicine\/photo10_sp.webp\" alt=\"Drafting a Roadmap for Regenerative Medicine Business and Development Plans\" class=\"sp\"><\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/section>\n<section class=\"secBox comBorBox\">\n<h2 class=\"headLine05\">Example of Solving Your Concern \u2461<br class=\"wpTag\"><br \/>\n\t(For Device Manufacturers and Reagent Manufacturers Considering Entering the Regenerative Medicine Industry)<\/h2>\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=\"Example of Solving Your Concern \u2461 (For Device Manufacturers and Reagent Manufacturers Considering Entering the Regenerative Medicine Industry)\"><\/div>\n<div class=\"txtBox\">\n<p class=\"wpTag\">We want to promote your products to regenerative medicine companies, but we lack knowledge of GCTP and are not confident in responding to supplier audits from regenerative medicine companies.<\/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=\"GCTP Education, Organizational Structure Building, and Mock Supplier Audits\"><\/div>\n<div class=\"txtBox\">\n<h3 class=\"headLine06\">GCTP Education, Organizational Structure Building, and Mock Supplier Audits<\/h3>\n<p class=\"wpTag\">In the field of regenerative medicine, it is necessary to comply with GCTP regulations. CM Plus can provide GCTP education support and organizational structure consulting compliant with GCTP regulations to device manufacturers and reagent manufacturers involved in the regenerative medicine industry. We also offer services such as conducting mock supplier audits based on the audits by regenerative medicine companies, performing GCTP compliance checks, and conducting GAP analyses. We provide CM Plus\u2019s unique one-stop service, offering consulting from various perspectives including product characteristics, GCTP, equipment, and more.<\/p>\n<div class=\"areaPhoto\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/service\/gmp_consulting\/regenerative_medicine\/photo11.webp\" alt=\"GCTP Education Support Organizational Structure Consulting Mock Supplier Audits\" class=\"pc\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/service\/gmp_consulting\/regenerative_medicine\/photo11_sp.webp\" alt=\"GCTP Education Support Organizational Structure Consulting Mock Supplier Audits\" class=\"sp\"><\/div>\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<div class=\"comBorBox comBorBox02\">\n<section class=\"validation\">\n<h2 class=\"headLine04\">Expert insights<\/h2>\n<p class=\"wpTag\">Please also refer to the articles on our information dissemination site, \u201cGMP Platform,\u201d operated by our company.<\/p>\n<div class=\"subValidation\">\n<div class=\"comImgBox validationImgBox\">\n<div class=\"photoBox\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/service\/gmp_consulting\/regenerative_medicine\/photo12.webp\" alt=\"\u201cRegenerative Medicine in Clinical Practice\u201d Series\"><\/div>\n<div class=\"textBox\">\n<h4 class=\"headLine07\">\u201cRegenerative Medicine in Clinical Practice\u201d Series<\/h4>\n<div class=\"comLinkP02\"><a href=\"https:\/\/www.gmp-platform.com\/article_detail.html?id=3550\" target=\"_blank\" rel=\"noopener noreferrer\">Regenerative Medicine in Clinical Practice [Part 1]<\/a><br class=\"wpTag\"><span class=\"subSpan\">(Japanese only)<\/span><\/div>\n<\/div>\n<\/div>\n<\/div>\n<div class=\"subValidation\">\n<div class=\"comImgBox validationImgBox\">\n<div class=\"photoBox\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/service\/gmp_consulting\/regenerative_medicine\/photo12.webp\" alt=\"\u201cThoughts on Quality Assurance for Regenerative Medicine and Related Products\u201d Series\"><\/div>\n<div class=\"textBox\">\n<h4 class=\"headLine07\">\u201cThoughts on Quality Assurance for Regenerative Medicine and Related Products\u201d Series<\/h4>\n<div class=\"comLinkP02\"><a href=\"https:\/\/www.gmp-platform.com\/article_detail.html?id=4961\" target=\"_blank\" rel=\"noopener noreferrer\">Thoughts on Quality Assurance for Regenerative Medicine and Related Products [Part 1]<\/a><br class=\"wpTag\"><span class=\"subSpan\">(Japanese only)<\/span><\/div>\n<\/div>\n<\/div>\n<\/div>\n<div class=\"subValidation\">\n<div class=\"comImgBox validationImgBox\">\n<div class=\"photoBox\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/service\/gmp_consulting\/regenerative_medicine\/photo13.webp\" alt=\"\u201cHow to Create Manufacturing Documents for Young Engineers in Regenerative Medicine\u201d Series\"><\/div>\n<div class=\"textBox\">\n<h4 class=\"headLine07\">\u201cHow to Create Manufacturing Documents for Young Engineers in Regenerative Medicine\u201d Series<\/h4>\n<div class=\"comLinkP02\"><a href=\"https:\/\/www.gmp-platform.com\/article_detail.html?id=8832\" target=\"_blank\" rel=\"noopener noreferrer\">How to Create Manufacturing Documents for Young Engineers in Regenerative Medicine [Part 1]<\/a><br class=\"wpTag\"><span class=\"subSpan\">(Japanese only)<\/span><\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/section>\n<\/div>\n<div class=\"comBorBox comBorBox02\">\n<section class=\"validation\">\n<h2 class=\"headLine04\">\u201cRegenerative Medicine &#038; Cell Therapy Products Exhibition\u201d to be Held<\/h2>\n<p class=\"wpTag\">Our life science information platform \u201ciVEXL\u201d will be hosting the \u201cRegenerative Medicine &#038; Cell Therapy Products Exhibition.\u201d Please feel free to visit and gather information.<\/p>\n<div class=\"subValidation\">\n<div class=\"comImgBox validationImgBox\">\n<div class=\"photoBox\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/service\/gmp_consulting\/regenerative_medicine\/photo14.webp\" alt=\"\u201cRegenerative Medicine &#038; Cell Therapy Products Exhibition\u201d to be Held\"><\/div>\n<div class=\"textBox\">\n<p class=\"wpTag\">Aiming for the practical application of regenerative medicine and cell therapy products, we will bring together the latest technologies and services from various companies, including contract services such as cell culture, devices and equipment, as well as storage and transportation solutions.<\/p>\n<div class=\"comLinkP02\"><a href=\"https:\/\/ivexl.com\/search-list_eEx-name.html?id=244\" target=\"_blank\" rel=\"noopener noreferrer\">For more information on the iVEXL \u201cRegenerative Medicine &#038; Cell Therapy Products Exhibition\u201d<\/a><br class=\"wpTag\"><span class=\"subSpan\">(Japanese only)<\/span><\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/section>\n<\/div>\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\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/common\/photo01.webp\" alt=\"Engineering, Project Management\"><\/span><br \/>\n<span class=\"subSpan\">Engineering, Project Management<\/span><br \/>\n<\/a><\/li>\n<li><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/support_for_training\/\"><br \/>\n<span class=\"photo\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/common\/photo03.webp\" alt=\"Education\/Training Support\"><\/span><br \/>\n<span class=\"subSpan\">Education\/Training Support<\/span><br \/>\n<\/a><\/li>\n<li><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/technology_information\/\">\n<div class=\"photo\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/en\/wp-content\/themes\/cmplus\/image\/common\/photo04.webp\" alt=\"Technical Information Services\"><\/div>\n<p><span class=\"subSpan\">Technical Information Services<\/span><br \/>\n<\/a><\/li>\n<\/ul>\n<\/section>\n<\/article>\n<aside id=\"sideBar\">\r\n\t<p class=\"sideTtl\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/\"><span class=\"txtSpan barlow\">Services<\/span><\/a><\/p>\r\n\t<ul id=\"menu-service\" class=\"sideList\"><li id=\"menu-item-238\" class=\"jsLi menu-item menu-item-type-post_type menu-item-object-page menu-item-has-children menu-item-238\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/engineering\/\">Engineering, Project Management<\/a>\n<ul class=\"sub-menu\">\n\t<li id=\"menu-item-253\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-253\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/engineering\/production_facility\/\">One-Stop Service for Production Facilities<\/a><\/li>\n\t<li id=\"menu-item-240\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-240\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/engineering\/construction_management\/\">About Construction Management<\/a><\/li>\n\t<li id=\"menu-item-239\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-239\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/engineering\/feature\/\">Construction Management by CM Plus<\/a><\/li>\n\t<li id=\"menu-item-6143\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-6143\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/engineering\/project_management_consultant\/\">Project Management Consultant (PMC)<\/a><\/li>\n\t<li id=\"menu-item-243\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-has-children menu-item-243\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/engineering\/project_flow\/\">Facility Construction<\/a>\n\t<ul class=\"sub-menu\">\n\t\t<li id=\"menu-item-245\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-245\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/engineering\/project_flow\/business_concept\/\">Business Concept<\/a><\/li>\n\t\t<li id=\"menu-item-246\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-246\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/engineering\/project_flow\/conceptual_design\/\">Conceptual Design<\/a><\/li>\n\t\t<li id=\"menu-item-247\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-247\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/engineering\/project_flow\/basic_design\/\">Basic Design<\/a><\/li>\n\t\t<li id=\"menu-item-248\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-248\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/engineering\/project_flow\/purocurement\/\">Procurement<\/a><\/li>\n\t\t<li id=\"menu-item-249\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-249\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/engineering\/project_flow\/detailed-design_construction\/\">Detailed Design \/ Production Management<\/a><\/li>\n\t\t<li id=\"menu-item-244\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-244\"><a href=\"https:\/\/cm-plus.co.jp\/en\/service\/engineering\/project_flow\/commissioning_qualification\/\">Trial Operation -Commissioning &#038; 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The scope of regenerative medicine products defined under the Pharmaceutical and Medical Device Act (commonly known as the PMD Act) is as follows: 1.Products in which cells from humans or animals have been cultured or otherwise processed, with the purposes of:a. Reconstruction, repair, or formation of the structure or function of the body of humans or animals.b. Treatment or prevention of diseases in humans or animals. 2.Products intended for the treatment [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":155,"menu_order":55,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":""},"keywords":[9,11,14],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v22.4 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Regenerative Medicine Consulting\uff5cCM Plus<\/title>\n<meta name=\"description\" content=\"Experienced consultants in regenerative medicine and cell therapy provide support with services tailored to your specific challenges.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/cm-plus.co.jp\/en\/service\/consulting\/regenerative_medicine\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta 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