Advice on Effective Regulatory Strategies in Various Therapeutic Areas

From the development planning of a drug or medical device to NDA approval, we prepare various application documents and reports under strict quality control within shortest timeline. Our experienced staff having wide range of expert knowledge in various therapeutic areas, proposes effective regulatory strategies.

work flow

Major Services

  • Support for Development of Documents for Clinical Trials and Post-Marketing Clinical Studies, etc (Clinical Trial Plan Notifications, Protocol, Informed Consent Written Information, Case Report Forms, Investigator’s Brochures, etc)
  • Support for the Development of the Various Reports for Clinical Trials (Adverse Drug Reaction Reports, Clinical Study Reports)
  • Support for the Development of Documents for Approval Applications and Reexamination Applications (Application Dossiers in Response to CTD, Reexamination Application Dossiers)
  • Support for the Development of Thesis Papers, Articles, etc
  • Support for the Development of Orphan Drug Designation Application Forms
  • Preparation or Revision of Interview Forms
  • Regulatory Consulting
  • Translation of English Reports into Japanese and Quality Control in Translation
  • Translation of Various Reports and Application Documents into English and Quality Control in Translation

  1. We actively employ human resources with a high level of expertise and emphasize education such as special education programs.
  2. By holding sufficient discussion with the client and by preparing written specifications and outlines of the reports at services commencement, we strive to fully understand client’s requests and incorporate requests into outcome.
  3. Through a standardized process of comprehensive documentation in accordance with established procedures, specifications and etc, we guarantee the quality of data.

[ Contact ] Business Development TEL +81-3-5804-7577 / FAX +81-3-5804-0361

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