Nonclinical Services


Medical Writing

  • 1.Service system

    LSIM has been entrusted with medical writing based on a wealth of experience accumulated over many years. Our team of experts in nonclinical pharmacology, pharmacokinetic, and toxicity studies as well as in application for regulatory approval of pharmaceuticals are committed to meet your needs.

  • 2.Range of service

    • 2.1Various documents in application of pharmaceuticals, cellular- and tissue-engineered medical products, and medical equipment for regulatory approvalF
      Writing support, translation, QC, and QA* in nonclinical sections (pharmacology, pharmacokinetic, and toxicity)
      * Available upon request.

      • œInvestigator's brochure (IB), Investigational medicinal product dossier (IMPD)

      • œModule 2 of CTD (global assessment, written summary, and tabulated summary)

      • œAddress inquiries (preparation of draft answer)

      • œNonclinical reports (translation)

    • 2.2Various documents in application of chemicals for approval (Chemical Substances Control Law): writing support, translation, and QC in toxicity sections

      • œToxicity study reports

      • œApplication forms (debrief report)

  • 3.Service flow

    Acceptance of order

    EVerification of work contents, specifics, preparation/QC procedures, schedule, and data provided


    EPreparation of drafts by person in charge
    EVerification of contents with a checklist

    Quality check

    EConfirmation of consistency between drafts and data provided by QC personnel
    EVerification of contents with a checklist
    EPreparation of QC report (checklist and drafts after QC review)

    Check by client

    EPreparation of revised versions reflecting sponsorfs feedback

    Quality check

    EQC check and preparation of QC report
    EQA check and preparation of QA report (as requested)

    Delivery of final version

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