Translation/QC

Our translators are seasoned professional with formidable subject matter experience. We also offer QC checks of various types of approval application materials.

Our services are managed by experienced coordinators, who choose the most appropriate translators for the job, be it clinical studies, pre-clinical studies, regulatory affairs or GMP guidelines, for example.

OUR SOLUTIONS

  • TRANSLATION/PROOFREADING/PREPARATION

    • Documents for registration of pharmaceutical products: common technical document (CTD), minutes of PMDA/ initial consultation, inquiry, response, etc.
    • CSR, protocol, investigator’s brochure, etc.
    • Medical and pharmaceutical articles, books

  • QC CONSULTINGSERVICES

    • Application packages
    • Clinical development strategies (protocol)
    • Preparation of PMDA consultation materials(*You may receive advice from professionals in application)
    • Preparation of common technical document (CTD) in the sections on CMC, non-clinical studies, clinical studies and scientific articles for the following document types:

MEDICAL WRITING

Preparation of common technical document (CTD) in the sections on CMC, non-clinical studies, clinical studies and scientific articles for the following document types:

  • REGULATORY AFFAIRS

    • Common technical document (CTD), investigator’s brochure, minutes of PMDA consultation/ pre-application consultation/ initial consultation, inquiry, response to inquiry, guidelines, regulatory notification, pharmacopeia and contract
    • CMC of drug substance/ drug product
    • Specifications, manufacturing process, stability study and bioequivalence study(including dissolution test)
    • Non-clinical documents
    • Study reports on pharmacology/ toxicity and pharmacokinetics

  • CLINICAL DOCUMENTS

    • CSR, protocol, investigator’s brochure and SOP
    • PMS documents (in accordance with MedDRA)
    • CIOMS, package insert, PSUR and Line listing

    • MEDICAL DEVICES

    • Materials submitted with application for manufacturing or import approval and instructions for use, for the following main categories:
    • Pharmaceutical: Seeking/ creation, CMC (quality), non-clinical (pharmacology/ toxicity/ pharmacokinetics), clinical study, post-marketing surveillance, regulatory affairs, etc.
    • Medical: Basic medicine, clinical;　Medical Device; Food Analysis
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