Service Details
Range of Service
Various 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)
Various 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)
Service Flow
- Acceptance of order
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- Verification of work contents, specifics, preparation/QC procedures, schedule, and data provided
- Drafting
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- Preparation of drafts by person in charge
- Verification of contents with a checklist
- Quality check
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- 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
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- Preparation of revised versions reflecting client’s feedback
- Quality check
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- QC check and preparation of QC report
- QA check and preparation of QA report (as requested)
- Delivery of final version