Gathering "knowledge" together and offering solutions
For the purpose of ensuring quality at production facility of drugs/medical devices, we gather "knowledge" of first-rate consultants internationally and offers 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
Gathered "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 medical 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 keep attracting GMDP/QMS-related "knowedge" all the time.
From supplier audits and measures for better quality to audits and development of human resources. CM Plus has its own practical system to support our clients.
Along the product and production facility lifecycle, CM Plus provides our clients with consistent support from supplier audits and measures for better quality to audit support and development of human resources working at the facility.
We firmly support your efforts to establish quality in a practical way.
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' needs.
Scope of CM Plus GMDP/QMS consulting services
GMDP consulting services for drugs
For better GMDP control, audit support, education and training on GMDP, support for audit control/purchase control, and support for M&A, etc.
QMS consulting services for medical devices
Continuous improvement in terms of QMS, and support for entering the medical device industry
Consulting services for supporting development in regenerative medicine
Support for establishing quality systems for regenerative medical products/processed cells, and support for diagnosing/establishing facilities and equipment
Support for overseas plants, support for M&A, and interpretation for audits/inspections
Vietnam, Indonesia, China, Myanmar, India, Singapore, etc.
In terms of quality, CM Plus can help you if you want to:
■Prepare for a sudden inspection done by the authority
■Find a partner with whom we can work together to establish/improve our quality system in a concrete way
■Eliminate worry about potential issues and risks at our manufacturing facilities before our noses
■Persons who can serve as the auditor for manufacturing facilities of our contract manufacturers
■A partner who guides us in our effort to enter the drug and medical device industry
What CM Plus can do through our consulting services
■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 will make proposals from a comprehensive point of view on various topics from preparation of written procedures for supporting establishment/improvement of PQS and QMS, to better approach to store raw materials or flows at the facilities, and better operation at the site. The ability to smoothly carry out measures to make changes for better facilities is one of our advantages as a consultant who is also engaged in engineering.
■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 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. You 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.
Comments from our clients