Description of Business

Monitoring of Pharmaceuticals & Medical Device

• Explanation of Protocol and case report forms for primary investigator and its agreements.
• Request of clinical trials to medical institution and perform procedures for Contract of clinical trial.
• Correspondence with the results of IRB(institutional review board) deliberations.
• Working out of start-up meeting.
• Visiting medical institution to transmit information.
• Collection and checking of case report forms.
• Carrying out the source document verification.
• Produce the report on monitoring.

Regulatory affairs related service of Medical Device

1) Regulatory affairs consulting
• Investigation of application category; certification or approval.
• Planning from marketing approval/certification application through obtaining marketing approval/certification.
• Investigation of application dossier and consulting.
• Support for interview between third party certification organization and reviewing authority.
• Support for other regulatory affairs related items.

2) Items regarding marketing approval/certification application and marketing notification

• Required information submission for preparation of marketing approval/certification application and marketing notification.
• Support for preparation of marketing approval/certification application, STED (Summary of technical document) and attached data.
• Support for preparation of various notifications.
• Place an order for examination with outside research organization and its progress management.
• Support for responding third party certification organization and PMDA (pharmaceutical and medical device agency) inquiry.
• Support for other regulatory application related items.

Supporting medical device entry into Japanese market

• Application for license for marketing authorization holder.
• Application for accreditation of foreign manufacturers.
• Application for license of manufacturing package, labeling, storage for domestic use.
• Service as designated marketing authorization holder for foreign manufacturers.