Clinical Trial Notification and CXP compliance

We provide a wide range of services related to Clinical Trial Notification (CTN):

Selection and recommendation of cost-effective CROs for running your clinical trial in Japan
Interaction with PMDA throughout the CTN processInteraction with PMDA throughout the CTN process
Understand Body Language and communication
Preparation, review and submission to PMDA of all documents required for CTN
Timely response to PMDA queries
How to succeed in working with Japanese professionals
Trouble shooting and regular advice and guidance for a smooth CTN

GCP compliance in Japan 

Design and preparation of annual audit plan for Japan and provision of regular GCP compliance advice
Support during GCP audits for trial sites
Preparation for PMDA inspection and onsite management at both trial sites and sponsor sites
Lead and support pre-inspection site visits for PMDA inspections in Japan
Manage reporting and negotiation with PMDA and MHLW on GCP violation issues 

GLP compliance

Gap analysis on GLP requirements in Japan
Support for Data reliability inspection for PMDA
Creative solutions to meet PMDA requests on GLP compliance

GMP compliance in Japan 

GMP Evaluation and analysis
Education and guidance to company staff on GMP requirements and changes
Plan for inspection and improvement
GMP Document Management System
Establishment of GMP system (SOPs and standards)

We are your gateway for success in Japan

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