お問い合わせの方 03-6659-8083

ご来社の方 東京本社

ECTメディカル株式会社  /  ペット未病研究会

Mar 7

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.