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.

Services

QA Team AuditsOther Services
Drug, medical devices, regenerative medicine, investigator-initiated clinical trials, clinical studiesAuditing and assessment of a CRO/vendor
Medical institutions for clinical trialsQA Statements
Clinical trials related services (internal)Consultation on quality assurance systems
Clinical systemsPreparation of audit SOPs/checklists and training
Good Clinical Practice (GCP)Auditor dispatch services for a sponsor
Self-inspection of post-marketing surveillance

Project Management

Clinical Operations

Pharmacovigilance

Data Management

Statistical Analysis

Medical Writing

Consulting Services

Bioanalysis and GLP Analytical Services