Providing Global Audit Service
Our independent quality assurance (QA) department provides reliable service based on our expertise in Japan and other countries, ensuring reliability in the development of drugs, medical devices, and regenerative medicines. We utilize our knowledge from over 20 years of experience working with global clients, to efficiently perform intensive audit in terms of time and effort. Our services include quality assurance of clinical trials, auditing investigator-initiated clinical trials, and audit of GCP, GMP, and GLP sites. We provide proactive QA services in Japan, South Korea, Singapore, Taiwan, Malaysia, Hong Kong, the Philippines, China, Vietnam, Thailand, Indonesia, Australia, and New Zealand. Our member consists of auditors from Japan, US, South Korea and Taiwan and are capable of working in multiple languages.
Our Edge in Quality Assurance
Broad Experience in Multiple Trial Types
- We provide prompt audit service based on expertise accumulated through working with a wide range of clients performing quality assurance services. Our proactive global audit services are based on our broad experience working with domestic clients.
|QA Team Audits||Other Services|
|Drug, medical devices, regenerative medicine, investigator-initiated clinical trials, clinical studies||Auditing and assessment of a CRO／vendor|
|Medical institutions for clinical trials||QA Statements|
|Clinical trials related services (internal)||Consultation on quality assurance systems|
|Clinical systems||Preparation of audit SOPs／checklists and training|
|Good Clinical Practice (GCP)||Auditor dispatch services for a sponsor|
|Self-inspection of post-marketing surveillance|