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：
    Writing support, translation, QC, and QA^* in nonclinical sections (pharmacology, pharmacokinetic, and toxicity)
    * Available upon request.

    • ●Investigator's brochure (IB), Investigational medicinal product dossier (IMPD)

    • ●Module 2 of CTD (global assessment, written summary, and tabulated summary)

    • ●Address inquiries (preparation of draft answer)

    • ●Nonclinical reports (translation)

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

    • ●Toxicity study reports

    • ●Application forms (debrief report)

• 3.Service flow

  Acceptance of order

  ・Verification of work contents, specifics, preparation/QC procedures, schedule, and data provided

  Drafting

  ・Preparation of drafts by person in charge
  ・Verification of contents with a checklist

  Quality check

  ・Confirmation of consistency between drafts and data provided by QC personnel
  ・Verification of contents with a checklist
  ・Preparation of QC report (checklist and drafts after QC review)

  Check by client

  Finalization

  ・Preparation of revised versions reflecting sponsor’s feedback

  Quality check

  ・QC check and preparation of QC report
  ・QA check and preparation of QA report (as requested)

  Delivery of final version