Support for Regulatory Affairs/Medical Writing

Medical writing

MIC provides all essential support for the reports required for Approval / Certification (Japan Marketing License, Shonin, Ninsho) of products, including notification of clinical a study, reporting of adverse reactions, and preparation of clinical study report. MIC regulatory experts with long-term experience provide these services.


1.Support for the preparation of documents regarding notification of a clinical study
  • (1) Notification of a clinical study (draft) in compliance with SGML
  • (2) Protocol (draft)
  • (3) Informed Consent Form (draft)
  • (4) Case Report Form (draft)
  • (5) Investigator's Brochure (draft)

2.Support for the preparation of reports on adverse reactions regarding the investigational product

3.Support for preparation of clinical report

4.Support for the preparation of the summary of Approval / Certification (Japan Marketing License, Shonin, Ninsho) application
(Inquiry / Request for Brochure)
MIC Medical Corp.
Business development Dept.
Hidenori Numata
Tel: +81-3-6880-9650 Fax:+81-50-3153-1522
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(Please include you Company name, mailing address and email address in the inquiry form)

Direct Regulatory Affairs Dept.
Kenichi Sakamoto
Tel: +81-3-6880-9310 Fax:+81-3-6880-9314
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(Please include you Company name, mailing address and email address in the inquiry form)