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