Consulting

Home/ Services/ Consulting ServicesConsulting Gathering "knowledge" together and offering solutions For the purpose of ensuring quality at production sites of drugs/medical devices, we gather "knowledge" of first-rate consultants internationally and offer consulting services from the GMDP (GMP & GDP) / QMS / pharmaceutical regulatory affairs point of view. *GMP: Good Manufacturing Practice *GDP: Good Distribution Practice *QMS: Quality Management System Advantage of CM Plus's GMDP/QMS/Pharmaceutical Regulatory Affairs consulting services Advantage01 Gathering "knowledge", first-rate consultants from various areas CM Plus works not only with our own consultants but also with top-rate consultants around the globe. Consultants specialized in various areas such as manufacturing, QC, QA, pharmaceutical regulatory affairs, and interpretation for audits for drugs, medical devices, and regenerative medicine products would willingly help you The ability to put the skills and knowledge together for finding solutions is an advantage of CM Plus. Profiles of our consultants Advantage02 Attractiveness you can find in one of the biggest GMP information websites in Japan CM Plus is sharing GMP-related regulatory information on its website that is called "GMP Platform". The website is one of the biggest in Japan with more than 12,000 members who work mainly for industries of drugs and medical devices.CM Plus keeps attracting GMDP/QMS-related "knowedge" all the time. GMP Platform Advantage03 From supplier audits, quality system improvements, audits supports to developments of human resources.CM Plus has its own practical system to support our clients. Along a lifecyle of the product and production facility, CM Plus provides our clients with consistent support from supplier audits, quality system improvements, audit support and development of human resources working at the facility.We firmly support your efforts to establish quality in a practical way. Consulting by CM Plus GMDP consulting services for drugs For GMDP improvement, audit support, education and training on GMDP, support for supplier...

https://cm-plus.co.jp/en/service/consulting/

Pharmaceutical GMP & GDP Consulting

Home/ Services/ Consulting/ Pharmaceutical GMP & GDP Consulting ConsultingPharmaceutical GMP & GDP Consulting Do you have any of these wishes regarding building in quality? We want to prepare for regulatory inspections. We want a partner who can concretely advance the construction/improvement of quality systems. We want to eliminate concerns about problems and risks lurking in the manufacturing facility. We want personnel responsible for auditing external contractors’ manufacturing plants and raw material suppliers. We want to efficiently establish a quality system in new business areas. With CM Plus’s GMDP Consulting, we offer the following support for Regulatory inspections such as those by the FDA and PMDA: Mock inspections Inspection response training Back office support during inspections Assistance in responding to inspection observations findings Support for improving identified issues Interpretation for overseas audits Comprehensive proposals for the establishment construction and improvement of PQS, storage management of raw materials, facility workflow improvements, and on-site operational improvements. Our strength includes the smooth proposal of facility improvements, supported by our in-house engineering consultants. By conducting GAP analysis, we first clarify the discrepancies (gaps) between the “current state” and the “desired future state” of the manufacturing site. We identify hidden risks and issues from both equipment/facility and quality system perspectives and provide improvement proposals. Experienced consultants conduct quality audits on your behalf. We train GMP Auditors (inspectors). Based on extensive experience, we support the establishment of quality systems and preparation of procedures tailored to the scale of personnel and other conditions. Additionally, CM Plus houses regulatory and validation experts, allowing us to offer one-stop consultations for these matters as well. First-rate consultants in/outside Japan will support you fo quality improvement by providing GMDP improvement consulting services.   Support for improving A：Support for establishing/improving your quality system As to manufacturing control/quality control, which supports quality of drugs...

https://cm-plus.co.jp/en/service/consulting/gmdp_consulting/

QMS for Medical Devices

Home/ Services/ Consulting/ QMS for Medical Devices ConsultingQMS for Medical Devices Support for New Entry into the Medical Device Industry The global market size for medical devices is estimated to be approximately 30 trillion yen, with around 2.8 trillion yen in Japan alone. This market is large and attractive for new entrants; however, medical devices are subject to stringent regulations under the “Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices” (abbreviated as the Pharmaceuticals and Medical Devices Act or PMD Act). Even if a material or technology can be applied to medicine, there are significant hurdles to overcome in order to introduce it as a medical device to the market. CM Plus supports new entries by building a quality management system (QMS) based on the QMS Ordinance (ISO 13485) and conducting product design and development in accordance with the QMS from the early planning stages of medical devices, ensuring a smooth and irreversible entry into the market. Roadmap from Development to Market Launch of Medical Devices   “Medical Device Development Support Handbook” Revised in October 2023 From the Cabinet Secretariat (Healthcare and Medical Strategy Office), Ministry of Education, Culture, Sports, Science and Technology, Ministry of Health, Labour and Welfare, and Ministry of Economy, Trade and Industry ※indicates the scope of CM Plus’s medical device consulting services. Examples of Progression Steps within Japan STEP01 Acquisition of medical devices Marketing License and Registration of Manufacturing Business The manufacturing and marketing of medical devices in Japan must comply with the Pharmaceuticals and Medical Devices Act (PMD Act). To conduct manufacturing and marketing, it is necessary to obtain a medical devices marketing license, and to conduct manufacturing, it is required to register as a manufacturing business. STEP02 Establishment of QMS (Quality Management System) In order to carry out...

https://cm-plus.co.jp/en/service/consulting/qms_consulting/

Education/Training Support

Home/ Services/ Education/Training Support ServicesEducation/Training Support We provide education that encourages thinking “why,” not just acquiring knowledge. In the manufacturing and sale of pharmaceuticals and other products, it is essential to comply with various regulations, starting with the Pharmaceutical and Medical Device Act. Moreover, as these products directly affect human and animal lives and health, there is a social mission and responsibility to maintain proper quality while ensuring a stable supply. Therefore, it is required for companies to plan and implement education and training programs for all employees that include mandatory GMP training, compliance, morality, and the ability to think and make judgments. Our education and training support services based on the “GMP Platform,” provide educational content focused on quality (manufacturing). Additionally, we offer education and training support programs that bring together various information and the expertise of our experienced consultants. Through those services, CM Plus assist in solving our clients' issues from the perspectives of both the quality system and the education system. Features of CM Plus Education/Training Support Aggregate of "knowledge", which keeps sharing the latest information On "GMP Platform" (https://www.gmp-platform.com/en/), CM Plus's web service, you can read the latest information and regulations in life science industries, and serial articles. GMP Platform By registering for a free membership, you will be able to access the published information. You can gather information from a series of articles and news topics related to GMDP/QMS. GMP Platform You can learn at any time and as much as you need CM Plus offers eLearning courses which you can use at any time and any place such as open seminars held at a venue or on-site seminars held at our client's office. We offer tailor-made educational programs for companies which are too busy to develop and carry out their own programs. CM Plus's...

https://cm-plus.co.jp/en/service/support_for_training/

Consultants

https://cm-plus.co.jp/en/consultant_profiles/