Company Profile

Quality assurance is the basis of corporate activities, and the quality management system should be established so that the business can be extended. However, if the direction and method are incorrect, not only will customer satisfaction decrease, but quality costs will increase, which will have a negative impact on the business. With the keywords of “fostering a quality culture,” “cost rationality,” and “compliance with the latest regulations,” Office Kiseki  assists the establishment and operation of a quality management system that satisfies a client.

Corporate Philosophy

As an expert in quality system standardization and global regulatory affairs, Office Kiseki Co., Ltd. provides reasonable consulting at a practical level to customers who are tasked with establishing and operating a quality management system, applying to regulatory authorities, and responding to inspections.

Profile

• Basic search for pharmaceuticals, evaluation of ADME(8 years)
• Quality control of pharmaceuticals (physicochemical testing, microbial testing, bioassay) (4 years)
• Pharmaceutical GMP practice and management (20 years)
• GMP regulatory inspections (7 USFDA, 3 EMA, 2 TGA, 1 KFDA)
• Domestic and overseas pharmaceutical affairs applications (preparation of CTD and DMF, registration application, inquiry response)
• Technology transfer to overseas manufacturers (India, China)
• Medical devices QMS (14 years)
• Cosmetics GMP (5 years)
• Supplier audits (70 companies in the past 5 years)
• Japanese restaurant business (11 years)

Industry Activities

・ISPE Guide: Cleaning Validation Lifecycle – Applications, Methods, and Controls Writing Task
・Team Japan Representative
・ISPE Containment COP member

Office Kiseki Co., Ltd.
CEO　Hiroaki Matsumoto