Consulting

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

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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.

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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.

Scope of CM Plus GMDP/QMS Consulting Services

GMDP Consulting Services for Medicines

First-rate consultants in/outside Japan will support you for better quality by providing advice for better GMDP control.

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A: Support for establishing/improving your quality system

As to manufacturing control/quality control, which supports quality of drugs and related to all the activities from B to E shown below, CM Plus provides support for establishment and continuous improvement according to guidelines such as “PIC/S GMP Guide Part I/II”. We makes proposals how it should be about SOP’s document system established based on your quality policies, and provide support for establishing written procedures and records which support quality at the manufacturing site.

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B: Proposals for better facility and equipment systems

CM Plus reviews the layout, cleanliness classification, the flow of personnel and materials according to GMP then makes proposals of measures for improvement. We also coach our clients in qualification such as DQ, IQ, and OQ, and in how to fill in records. The records will also be reviewed. In this way, we provide our clients with support for qualification which can be implemented smoothly and you won’t need to carry out the process again. Also, we provide our clients with consulting services on CSV according to the latest information such as “PIC/S GMP Guide Annex 11”.

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C: Support for establishing/improving your raw material system

CM Plus makes proposals of appropriate control methods for selecting suppliers, storing raw materials and products, putting materials in/out of warehouses, and distribution.

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D: Support for establishing/improving lab control system

CM Plus provides support for establishing systems to control the whole lab including measures to ensuring data integrity from control of samples, reference standards and reagents to qualification, maintenance, and calibration of laboratory instruments, and method validation.

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E: Support for validation activities

After the publication of “FDA Guidance” in 2011 and the revision of “PIC/S GMP Guide Annex 15” in 2015, the concept of process validation drastically changed and was positioned as continuous activities to be done throughout product lifecycle. CM Plus reviews our clients’ CMC data and propose effective approaches so that you can ensure appropriate traceability of your evidence data accumulated during development of your products. Also, we will support our clients for developing continuous improvement based on product quality reviews.

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F: Audit support

CM Plus performs mock audits with our auditors who have experience of audits in Japan/U.S./Europe or used to be the auditor at the authority. Based on the mock audits, we provide our clients with appropriate instructions and proposals for improvement based on the client’s status of preparation. In addition, we provide support at backyard during audits and for handling findings provided after audits.

  • Mock audits performed by our auditors who have experience of audits in Japan/U.S./Europe or used to be the auditor at the authority (a simulation performed in the same way as the actual audits)
  • Providing support for preparing various documents and meeting with the authority
  • Examples of our support for FDA audits: providing support for preparing packages for preliminary meetings (Type C Meeting) and attending meetings
  • Giving advice at backyard during audits about preparation of materials and responses
  • Providing support for preparing written agreements for making improvement in response to findings provided during an audit and for preparing written responses

Support for GMDP Education and Training

For drug production activities, it is important to give your employees effective education on GMDP continuously and make them understand GMDP correctly. CM Plus offers you “eLearning” and “open seminars” for individuals, and “on-site seminars” for organizations.

Pharmaceutical Regulatory Affairs Consulting

Our experts offer pharmaceutical regulatory affairs consulting services with abundant practical experience of the industry to meet our customers’ needs.

  • Regulatory Application Strategy
  • Building Internal Systems such as GQP / GVP
  • Various Consultations with the Pharmaceuticals and Medical Devices Agency (PMDA)
  • Support for Manufacturing/Marketing Business License for Pharmaceutical Products etc./ Manufacturing Business License/ Application for Accreditation of Foreign Manufacturers (including Support for Inquiry Response)
  • Business Support for Creating Approval Application Forms and Application Materials
  • Business Support for Partial Change, minor change (including support for inquiry response)

CM Plus has obtained the first-class and second-class marketing licenses for pharmaceuticals. We will provide services as a Designated Marketing Authorization Holder (D-MAH) for foreign manufacturers who have entered the Japanese market and consider importing and selling.

※Link to the CM Plus Japan site.

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