Drug application-related document writing

  • Clinical Study Reports (CSR): Clinical studies
  • Common Technical Document (CTD): Non-clinical and clinical studies
  • Queries and responses
  • Others (adverse event narratives, protocols, review of ICF etc.)

Article writing

  • Review (pathology, treatment, clinical results)
  • Clinical trial (RCT, observational research, case reports, retro research, PMS)
  • Non-clinical (toxicity, pharmacokinetics, pharmacology)
  • Survey (questionnaire, web survey)

We support the entire process of publication which includes searching of submission guideline for target journals, drafting outline, English proofreading, publishing support, and review.


  • Check the consistency of various English or Japanese documents
  • Check the validity check of various English or Japanese documents
  • Check the format

Project management system

FunctionRoles and Responsibility
Business Manager
Receipt and delivery of related materials and deliverables, point-of-contact for delivery process.
Appoint person in charge for each task.
Management of work in progress.
(Writer and Editor)
Drafting and editing the documents.
QC ManagerCheck the completeness of quality inspection conducted by QC check (confirm the points checked, any questions or remarks).
Other quality inspection related works.
QC CheckQuality inspection work of draft documents prepared by the writers.
Check the following based on the check list: any content and instructions mismatch, overall consistency.
Business Process CheckCheck whether the work is performed according to the previously agreed procedures (operation manual, work instructions etc.).


Major customers

  • Pharmaceutical company: more than 30 companies
  • CRO:8 companies
  • Academia:4 universities