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
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.
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.
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
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GMDP consulting services for drugs
For GMDP improvement, audit support, education and training on GMDP, support for supplier control/purchase control, and support for M&A, etc.
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QMS consulting services for medical devices
Continuous improvement in terms of QMS, and support for entering the medical device industry
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Regulatory Affairs Consulting
From Development Regulatory Affairs, CMC Regulatory Affairs, to Regulatory Compliance
From consulting services on regulatory submission strategies, to support for various consultations with the Pharmaceuticals and Medical Devices Agency (PMDA). -
Validation Consulting
From preparation of Validation Master Plans, support for risk assessment,
prepartion of protocols for implementation of qualification (DQ, IQ, OQ, PQ) to execution support -
Regenerative Medicine Consulting
Support for establishment of quality system, and diagnosis/construction of facilities and equipment for Regenerative Medicine Products/Cell processing products
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Contamination Control Strategy (CCS) Consulting
Seminar on CCS establishment, CCS gap analysis and proposal of study methods for each CCS, support for CCS document preparation
Other Services
Overseas Project Management
- GMP Consulting
CM Plus supports substitutional audits, and education and training for staff. - Facility and Equipment Maintenance
CM Plus supports the design, construction management, installation, and validation related to the renovation and expansion of facilities and equipment.
Cross Border Project Management
M&A Business Support
Due diligence of production facilities is an important factor in assessing acquisition value.
CM Plus conducts proper due diligence from the perspectives of facility design, construction, maintenance, operation systems, and GMDP to support your M&A activities.
Interpretation
Our multilingual staff, fluent in “Japanese + English + α”, provide business support through interpretation, mainly in China, Vietnam, and Indonesia.
- Inspection Interpretation
(Interpretation for inspections in Japan by foreign authorities and inspections in China, Vietnam, and Indonesia by PMDA) - Mock Audit Interpretation
(Japan, China, Vietnam, Indonesia) - Quality Audit Interpretation
(Interpretation for audits in Japan by overseas companies and audits in China, Vietnam, and Indonesia by Japanese companies)
In terms of quality, CM Plus can help you if you want to:
- Eliminate worry about potential issues and risks at our manufacturing facilities
- Find a partner with whom we can work together to establish/improve our quality system in a concrete way
- Prepare for regulatory inspections
- Persons who can serve as the auditor for manufacturing facilities of our contract manufacturers
- Partners to guide us through regulatory affairs when entering the pharmaceutical and medical device industry from other industries
What CM Plus can do through our consulting services
- In GAP analysis, differences between “the ideal condition” and “the reality” of your facilities will become clear. Then we will find out issues including hidden risks in terms of both your buildings and facilities and your quality management system and make a proposal for improvement.
- We will make 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.
- We can perform mock audits according to the same plan as actual ones and provide with some feedback. The auditors have experience of audits in Japan/U.S./Europe or used to be the auditor at the authority.
- We also provide our clients with our systematic GMP auditor training program for Japanese pharmaceutical companies. Also, you can use our experienced consultants as the auditor. We can also find your interpreters for audits in other countries.
- Our consulting services are well received by our clients. According to some comments from our clients, our commentaries on regulations such as the latest guidance which are often difficult to understand are easy to understand for beginners and persons who have been recently appointed.
