Medical Writing (Post-Marketing Surveillance)

About Us

We employ experts that provide full support for all aspects of pharmaceutical writing regarding post-marketing surveillance.

In a short period of time and under strict quality control, we can prepare various application documents and reports required after pharmaceutical products approval applications.
Our skilled staff not only ensure compliance with various regulations and guidelines but also responds flexibly to the client`s requests for proactive proposals and consultation on the research plan to efficiently produce high-quality documents.

EPS Features


  • With extensive expertise we offer suggestions on policies to be included in the reports.
  • We also offer consultation regarding surveillance plans for post-marketing surveillance, etc.

High Quality

  • We create easy-to-read and high-quality documents.
  • We work closely with the statistical analysis department to provide scientific, fair, and accurate documentation.
  • Quality is assured through uniform processes, such as ensuring that records are kept in accordance with procedure specifications.
  • Periodic safety reports and reexamination application materials, including routine pharmacovigilance and additional pharmacovigilance reports are made by the same department, thus providing uniform terminology throughout the documents.

Active Collaboration with other Departments

  • We contribute to the efficiency and quality improvement of documentation by actively and independently collaborating with other departments.
    • Post-marketing Surveillance, etc.: Collaboration with data management and statistical analysis.
      • Prompt inter-departmental inquiries when questions arise.
      • Review and share any suspicions that arise, making improvements to prevent it from happening in the future.
    • Routine pharmacovigilance: Collaboration with the Pharmacovigilance Department.
      • Transfer of individual subject data required for reporting between departments.
      • Share feedback from customers.

Excellent Human Resources

  • We actively recruit highly capable personnel and train them based on our unique professional education program.


High-Quality Documents Created by Qualified Professionals

image of Medical Writing (Post-Marketing Surveillance)

We respond quickly and accurately to a wide range of requests with quality assurance based on a uniform process and high-quality work that makes full use of our staff`s extensive knowledge.

Target Documents

  • Clinical study protocols, implementation guidelines, and informed consent documents related to post-marketing surveillance.
  • Periodic safety report.
  • Surveillance result report.
  • Reexamination application documents.
  • Feedback documents for medical institutions.
  • Articles, conference presentation documents, etc.

Other Services

  • Japanese to English and English to Japanese translations.
  • Quality control of various reports and application documents.
  • Pharmaceutical affairs consulting for post-marketing surveillance, reexamination applications, etc. (response to inquiries).
  • Coordination within the client company for the preparation of periodic safety reports, etc. (review requests, compilation of review results, preparation of necessary records, etc.).
  • Support for submission of periodic safety reports and reexamination application documents to authorities (from CD creation to submission).