Total coordination of quality management system

Office Kiseki is the total coordinator of the Quality Management System (QMS).

Based on more than 30 years of experience in R&D, regulatory affairs, quality audits, and global operations, we support establishment, operation, maintenance, and update of quality management systems for various industries.

Applicable QMS Area

  • Quality management system (ISO9001)
  • Pharmaceutical GMP (JGMP, cGMP, EUGMP, ICH, PIC/S GMP)
  • Investigational drug GMP
  • Medical device QMS (ISO13485)
  • Cosmetics GMP (ISO22716)
  • Cosmetic raw material GMP (EFfCI)
  • Food GMP (ISO22000/FSSC 22000), HACCP
  • Primary packaging materials for pharmaceuticals QMS (ISO15378)
  • Laboratories (ISO17025)
  • Pharmaceutical equipment design, containment of high potency compound, asepticmanagement, etc.

Regulatory GMP Inspections

We support inspections and inquiries by regulatory authorities such as the United States, Europe, Australia, and South Korea to ensure GMP compliance.

We provide pre-inspection training, mock inspections, and preparation of documents at the preparatory stage. We also support contract supplier audits in supplier management.

Pharmaceutical Affairs (domestic and overseas)

We support in detail the structure and contents of domestic and overseas pharmaceutical affairs applications (CTDs), including the actual creation.

GMP, ISO Education and Training

The quality management system requires the top-down management and the understanding of all employees. In addition to providing support to the client’s site for fostering a quality culture, we will provide education and training based on the latest guidelines and industry trends.

Food and Beverage Service Business

Japanese Kaiseki restaurant “Rihaku” offers a limited number of Japanese traditional dishes. “First Class Groen” also offers Obento and cooking lesson focusing on vegetarian cuisine.

Japanese Kaiseki restaurant “Rihaku”