Consultation

Services

We support domestic and international pharmaceutical companies and biotech ventures in solving challenges at each phase of cell and gene therapy development and manufacturing.


Product Development Support：We support the process from development seeds to the manufacturing of clinical trial products.
Regulatory Compliance Support：We assist with compliance to various regulations.
QMS Construction Support：We support the establishment of pharmaceutical quality systems.
Audit Response Support：We help with responding to GCTP conformity inspections.
Facility Design & Specification Review Support / CPC Operation Support：We provide support from the design to the operation of CPC facilities.
Commercial Manufacturing Support / Clinical Trial Product Manufacturing Support / Electronic Integrated System：We support the development of manufacturing systems and the digitization of records.
 

Flow of Service

Contact

 

Service Catalog

Download Materials


 
Product Development Support

・Product Specification Design Support

・Quality Management Strategy Development Support

・Manufacturing/Test Method Development Support

・Technology Transfer Support

・Aseptic Operation Operator Training



 
Regulatory Compliance Support

・Cartagena Application Support

・GCTP Compliance Investigation Response and Inquiry Support

・Gap Analysis between GMP/GCTP and Your Company's Current Status

・Business License Application Support



 
QMS Development Support

・Support for Developing and Maintaining Manufacturing SOPs and QC Testing SOPs

・QMS SOP Creation Support (Deviations, Changes, Recalls, Quality Information, Self-Inspection, Training, Documentation, etc.)

・Support for Building GCTP Organization



 
Audit Response Support

・Mock Audit

・Audit Response Training


 
Equipment Design/Specification Review Support

・Facility Design Review

・Equipment/Facility Acceptance Testing Plan and Report Review

・Validation Plan and Report Review


Equipment Management Support 
・Calibration and Maintenance Plan/Report Review

Calibration and Maintenance Plan/Report Review

・Support for Developing Hygiene Management Programs
・Operational Improvement Support


 
Support for Commercial Manufacturing

・Support for the Development/Improvement of Pharmaceutical Quality Systems

・GMP Training
・DI Training

・Supplier Management Agency and Support

・Self-Inspection Agency and Support

・Support for Raw Material Management


Support for Clinical Trial Product Manufacturing

・GMP Training for Investigational Drugs
・DI Training


Electronic Integrated System

・Support for the Implementation of an IT Integrated Manufacturing Management System
・Consulting for the Development of Automated Culture Equipment

Achievements

Preparation for Commercial Manufacturing of Regenerative Medicine Products 

Autologous Synovial Mesenchymal Stem Cells

・Preparation of Manufacturing Procedures

・Preparation of Quality Control Test Procedures

・Supplier Management Agency

・Raw Material Management

・Preparation of Validation Plans



 

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