Three S Japan Co., Ltd.

is a group of professionals who are specialized in product development of drugs, quasi-drugs, agrochemicals, etc. Our rich knowledge and abundant experiences in these fields must be exploited by clients in various situations during their product development.

flow of services

Support for drug development  

Experts in various fields of CMC and non-clinical studies give support to clients in preparing for the clinical trials and NDA.

Planning of study schedules

  • -- We help clients decide types and scales of studies necessary for clinical trials and NDA

Support for the preparation of study protocol

  • -- Preparation of study protocols to be entrusted to outsourcing facilities

Research and selection of outside facilities to entrust the studies/Supporting clientsf research into the facilities

  • -- Research and selection of the appropriate outsourcing facilities to carry out studies
  • -- Confirmation that how the outsourced studies are proceeding in the contracted facilities

Evaluation of study reports

  • -- Evaluation of the study reports made by contracted facilities
  • -- We can offer a pathological peer review for histopathological findings.
  • -- Response to inquiries on NDA

Organization that makes it possible for the perfect task performance

Evaluation group

Document preparation group

QC group

Translation group

Document management group

Support for NDA documents
-- Services to meet regulatory requirements  
-- Translation services  

Preparation of IB

  • -- Translation of foreign clinical trial documents between Japanese and English.
  • -- Preparation and revision of IB in the Japanese language
  • -- Verification of the consistency between the original IB and study reports

Preparation of CTD

  • -- Translation of foreign CTD (into Japanese)
  • -- Preparation of CTD in the Japanese language
  • -- Verification of the consistency between the original CTD and study reports

Support for QC

Verification of the consistency between the original IB and study reports


Verification of the consistency between the original CTD and study reports

Support for managingclientsf facilities and organizations

Helping clients establish well-organized GMP/GLP systems

  • -- Reviewing the GMP/GLP organizations and their management
  • -- Preparation of SOP drafts/Review of SOPs