{"id":163,"date":"2024-04-19T16:39:56","date_gmt":"2024-04-19T07:39:56","guid":{"rendered":"https:\/\/cm-plus.co.jp\/id\/?page_id=163"},"modified":"2025-09-25T15:33:58","modified_gmt":"2025-09-25T06:33:58","slug":"regulatory_affairs","status":"publish","type":"page","link":"https:\/\/cm-plus.co.jp\/id\/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\/id\/\">Beranda<\/a>\/<\/li>\n<li><a href=\"https:\/\/cm-plus.co.jp\/id\/service\/\">Layanan<\/a>\/<\/li>\n<li><a href=\"https:\/\/cm-plus.co.jp\/id\/service\/consulting\/\">Konsultasi<\/a>\/<\/li>\n<li>Konsultasi Urusan Regulasi<\/li>\n<\/ul>\n<\/div>\n<div class=\"h1Sub\">\n<div class=\"content\">\n<h1 class=\"h1Ttl\"><span class=\"subSpan\">Konsultasi<\/span><br class=\"wpTag\">Konsultasi Urusan Regulasi<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\/id\/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\/id\/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\/id\/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\">Siklus hidup farmasi dan tugas di setiap langkahnya<\/h2>\n<p class=\"comTxt\">Setiap langkah dalam siklus hidup farmasi melibatkan tugas-tugas berikut:<\/p>\n<div class=\"biPhoto\">\n<img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/id\/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\/id\/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>* Garis bawah merah menunjukkan cakupan layanan konsultasi regulasi CM Plus.<\/li>\n<\/ul>\n<\/section>\n<section class=\"sec02 secBox\">\n<h2 class=\"headLine05\">Konsultasi Urusan Regulasi Farmasi dari CM Plus<\/h2>\n<p class=\"comTxt\">Para ahli kami menawarkan layanan konsultasi urusan regulasi farmasi dengan <strong>pengalaman praktis yang melimpah<\/strong> di industri ini untuk memenuhi kebutuhan pelanggan kami.<\/p>\n<ul class=\"comRaiList\">\n<li>Strategi Aplikasi Regulasi<\/li>\n<li>Membangun Sistem Internal seperti GQP \/ GVP<\/li>\n<li>Berbagai Konsultasi dengan Badan Farmasi dan Alat Kesehatan (PMDA)<\/li>\n<li>Dukungan untuk Lisensi Bisnis Manufaktur\/Pemasaran untuk Produk Farmasi, dll.\/ Lisensi Bisnis Manufaktur\/ Aplikasi untuk Akreditasi Produsen Asing (termasuk Dukungan untuk Respons Pertanyaan) <\/li>\n<li>Dukungan Bisnis untuk Membuat Formulir Aplikasi Persetujuan dan Materi Aplikasi<\/li>\n<li>Dukungan Bisnis untuk Perubahan Sebagian, perubahan kecil (termasuk dukungan untuk respon pertanyaan) <\/li>\n<\/ul>\n<\/section>\n<section class=\"sec03 secBox\">\n<h2 class=\"headLine05\">Pelanggan Mendapat Manfaat dari Konsultasi Urusan Regulasi Farmasi CM Plus<\/h2>\n<div class=\"comExplainBox pink\">\n<h3 class=\"headLine06\"><span class=\"num barlow\">1.<\/span><span class=\"wpTag\"> Layanan Konsultasi Urusan Regulasi di semua tahap, dari Pengembangan hingga Pasca Pemasaran<\/span><\/h3>\n<p class=\"wpTag\">CM Plus menyediakan layanan konsultasi untuk pengembangan urusan regulasi, urusan regulasi CMC, dan urusan regulasi farmasi <strong>di semua tahap, mulai dari tahap pengembangan, pengajuan persetujuan, produksi, hingga pasca pemasaran.<\/strong> Kami dapat menangani obat baru, obat generik, obat yang sudah lama terdaftar (setelah masa pemeriksaan ulang), dan berbagai jenis obat.<\/p>\n<\/div>\n<div class=\"comExplainBox pink\">\n<h3 class=\"headLine06\"><span class=\"num barlow\">2.<\/span><span class=\"wpTag\">Layanan Konsultasi Urusan Regulasi <span class=\"red\">Bekerja sama dengan Layanan Konsultasi GMP.<\/span><\/span><\/h3>\n<p class=\"wpTag\">CM Plus menyediakan dua layanan. Yang pertama adalah \u201clayanan konsultasi GMP, dari perspektif departemen jaminan mutu QA dan manufaktur GMP\u201d (dukungan di tempat). Yang kedua adalah \u201clayanan konsultasi urusan regulasi farmasi, dari perspektif interpretasi regulasi dan prosedur dokumen\u201d (kami menyediakan layanan konsultasi respons regulasi kepada otoritas regulasi, dari aplikasi hingga respons pertanyaan). Menggabungkan kedua layanan ini memungkinkan kami untuk menyediakan <strong>layanan konsultasi GMP, QA, dan regulasi kolaboratif yang lebih sesuai untuk lokasi.<\/strong>.<\/p>\n<\/div>\n<div class=\"biPhoto\">\n<img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/id\/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\/id\/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\">Pemegang Otorisasi Pemasaran Tertunjuk <br class=\"wpTag\">dan Pengasuh Klinis Dalam Negeri<\/h2>\n<p class=\"comTxt\">CM Plus telah memperoleh lisensi pemasaran kelas satu dan kelas dua untuk obat-obatan. Kami dapat ditunjuk sebagai <strong>Pemegang Otorisasi Pemasaran Tertunjuk (D-MAH)<\/strong> untuk perusahaan yang tidak memiliki perusahaan yang berdiri di Jepang. Kami juga menyediakan layanan dukungan apa pun untuk uji klinis di Jepang yang sesuai dengan Peraturan Menteri GCP Jepang sebagai  <strong>Pengasuh Klinis Dalam Negeri (ICCC: Pasal 15 dalam Peraturan Menteri GCP) (peran sponsor di Jepang)<\/strong> <\/p>\n<div class=\"biPhoto\">\n<img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/id\/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\/id\/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\">Layanan Pemegang Otorisasi Pemasaran Tertunjuk (D-MAH)<\/h3>\n<p class=\"comTxt comTxt01\">Layanan ini memungkinkan produsen asing untuk memasuki pasar Jepang untuk produk farmasi secara sukarela.<\/p>\n<div class=\"comImgBox\">\n<div class=\"photoBox\">\n<div class=\"biPhoto\">\n<img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/id\/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\/id\/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\">Jika produsen asing tidak memiliki basis operasi bisnis di Jepang untuk penjualan obat-obatan dan alat kesehatan, maka perlu menunjuk satu pemegang lisensi bisnis manufaktur\/pemasaran di Jepang.<\/p>\n<p class=\"wpTag\"> CM Plus telah memperoleh lisensi pemasaran kelas satu dan kelas dua untuk obat-obatan. Kami akan menyediakan layanan sebagai Pemegang Otorisasi Pemasaran Tertunjuk (D-MAH) bagi produsen asing yang telah memasuki pasar Jepang dan mempertimbangkan untuk mengimpor dan menjual.<\/p>\n<\/div>\n<\/div>\n<h3 class=\"headLine06\">Layanan Perawat Klinis Dalam Negeri (ICCC)<\/h3>\n<p class=\"comTxt comTxt01\">Layanan ini memungkinkan uji klinis dilakukan di Jepang atas nama perusahaan farmasi luar negeri (perusahaan farmasi, usaha penemuan obat, dll.) tanpa badan hukum.<\/p>\n<div class=\"comImgBox\">\n<div class=\"photoBox photoBox01\">\n<div class=\"biPhoto\">\n<img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/id\/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\/id\/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\">Ketika perusahaan tanpa badan hukum di Jepang melakukan uji klinis di Jepang, perlu untuk mencegah terjadinya atau penyebaran bahaya kesehatan yang disebabkan oleh obat yang diteliti. Diperlukan untuk menunjuk orang yang beralamat di Jepang sebagai orang yang dapat meminta uji klinis atas nama orang tersebut.<\/p>\n<p class=\"wpTag\"> Sebagai mitra pengembangan klinis, CM Plus akan memainkan peran sponsor di Jepang (ICCC: Pasal 15 dalam Peraturan Menteri GCP) atas nama perusahaan farmasi tanpa basis bisnis di Jepang.<\/p>\n<\/div>\n<\/div>\n<\/section>\n<section class=\"sec05 secBox comBorBox\">\n<h2 class=\"headLine05\">Apakah Anda memiliki masalah berikut?<\/h2>\n<h3 class=\"headLine06\">Untuk Perusahaan Luar Negeri<\/h3>\n<div class=\"comTalkBox\">\n<div class=\"area\">\n<div class=\"peo\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/id\/wp-content\/themes\/cmplus\/image\/common\/com_peo01.webp\" alt=\"For Overseas Companies\"><\/div>\n<div class=\"txtBox\">\n<p class=\"txt01\"><strong>Bahkan jika Kami tidak memiliki perusahaan basis bisnis di Jepang, dapatkah Kami memperoleh persetujuan Manufaktur\/pemasaran produk farmasi tanpa memberikan lisensi kepada produk tersebut?<\/strong><\/p>\n<\/div>\n<\/div>\n<div class=\"arrow\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/id\/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\/id\/wp-content\/themes\/cmplus\/image\/common\/com_peo02.webp\" alt=\"For Overseas Companies\"><\/div>\n<div class=\"txtBox\">\n<p class=\"wpTag\">CM Plus telah memperoleh lisensi bisnis untuk lisensi pemasaran kelas satu dan kelas dua untuk farmasi. <strong>Penunjukan CM Plus sebagai Pemegang Otorisasi Pemasaran Tertunjuk (D-MAH) memungkinkan untuk mengajukan persetujuan khusus asing.<\/strong> Anda dapat menggunakannya untuk mengajukan persetujuan Pemasaran di Jepang.<\/p>\n<\/div>\n<\/div>\n<div class=\"area\">\n<div class=\"peo\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/id\/wp-content\/themes\/cmplus\/image\/common\/com_peo03.webp\" alt=\"For Overseas Companies\"><\/div>\n<div class=\"txtBox\">\n<p class=\"wpTag\"><strong>Apakah mungkin untuk melakukan uji klinis di Jepang meskipun tidak ada perusahaan yang berbasis di Jepang?<\/strong><\/p>\n<\/div>\n<\/div>\n<div class=\"arrow\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/id\/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\/id\/wp-content\/themes\/cmplus\/image\/common\/com_peo02.webp\" alt=\"For Overseas Companies\"><\/div>\n<div class=\"txtBox\">\n<p class=\"wpTag\"><strong>Dengan menunjuk CM Plus sebagai In-Country Clinical Caretaker (ICCC), uji klinis dapat dilakukan di Jepang sesuai kebutuhan.<\/strong> Selain itu, kami memiliki staf dengan pengalaman yang melimpah dalam pengembangan dan pemasaran, dan CMP dapat mengusulkan sistem implementasi uji klinis (CRO, lembaga medis, lembaga pengujian) di Jepang.<\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/section>\n<section class=\"comBorBox comBorBox02\">\n<h2 class=\"headLine04\">Konten Terkait<\/h2>\n<ul class=\"comLinkList\">\n<li><a href=\"https:\/\/cm-plus.co.jp\/id\/portfolio\/project_details\/\">\n<div class=\"photo\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/id\/wp-content\/themes\/cmplus\/image\/common\/photo05.webp\" alt=\"Projects\"><\/div>\n<p><span class=\"subSpan\">Proyek<\/span><br \/>\n<\/a><\/li>\n<li><a href=\"https:\/\/cm-plus.co.jp\/id\/about_cm_plus\/record\/\">\n<div class=\"photo\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/id\/wp-content\/themes\/cmplus\/image\/common\/photo06.webp\" alt=\"Performance by Numbers\"><\/div>\n<p><span class=\"subSpan\">Kinerja berdasarkan Angka<\/span><br \/>\n<\/a><\/li>\n<\/ul>\n<\/section>\n<section>\n<h2 class=\"headLine04\">Layanan Lainnya<\/h2>\n<ul class=\"comLinkList\">\n<li><a href=\"https:\/\/cm-plus.co.jp\/id\/service\/engineering\/\"><br \/>\n<span class=\"photo\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/id\/wp-content\/themes\/cmplus\/image\/common\/photo01.webp\" alt=\"Engineering, Project Management\"><\/span><br \/>\n<span class=\"subSpan\">Keahlian Teknik, Manajemen Proyek<\/span><br \/>\n<\/a><\/li>\n<li><a href=\"https:\/\/cm-plus.co.jp\/id\/service\/support_for_training\/\"><br \/>\n<span class=\"photo\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/id\/wp-content\/themes\/cmplus\/image\/common\/photo03.webp\" alt=\"Education\/Training Support\"><\/span><br \/>\n<span class=\"subSpan\">Dukungan Pendidikan\/ Pelatihan<\/span><br \/>\n<\/a><\/li>\n<li><a href=\"https:\/\/cm-plus.co.jp\/id\/service\/technology_information\/\">\n<div class=\"photo\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/id\/wp-content\/themes\/cmplus\/image\/common\/photo04.webp\" alt=\"Technical Information Services\"><\/div>\n<p><span class=\"subSpan\">Layanan Informasi Teknis<\/span><br 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class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-1872\"><a href=\"https:\/\/cm-plus.co.jp\/id\/service\/technology_information\/corressa\/\">CORRESSA<\/a><\/li>\n\t<li id=\"menu-item-5851\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-5851\"><a href=\"https:\/\/cm-plus.co.jp\/id\/service\/technology_information\/energy_management\/\">Solusi Manajemen Energi \u201cCMP Way\u201d<\/a><\/li>\n<\/ul>\n<\/li>\n<\/ul><\/aside><\/div>\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>Beranda\/ Layanan\/ Konsultasi\/ Konsultasi Urusan Regulasi KonsultasiKonsultasi Urusan Regulasi Siklus hidup farmasi dan tugas di setiap langkahnya Setiap langkah dalam siklus hidup farmasi melibatkan tugas-tugas berikut: &nbsp; * Garis bawah merah menunjukkan cakupan layanan konsultasi regulasi CM Plus. Konsultasi Urusan Regulasi Farmasi dari CM Plus Para ahli kami menawarkan layanan konsultasi urusan regulasi farmasi dengan pengalaman praktis yang melimpah di industri ini untuk memenuhi kebutuhan pelanggan kami. Strategi Aplikasi Regulasi Membangun Sistem Internal seperti GQP \/ GVP Berbagai Konsultasi dengan Badan Farmasi dan Alat Kesehatan (PMDA) Dukungan untuk Lisensi Bisnis Manufaktur\/Pemasaran untuk Produk Farmasi, dll.\/ Lisensi Bisnis Manufaktur\/ Aplikasi untuk Akreditasi Produsen Asing (termasuk Dukungan untuk Respons Pertanyaan) Dukungan Bisnis [&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],"class_list":["post-163","page","type-page","status-publish","hentry","keywords-gmpgdp"],"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 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