新藥開發及申請

One-Stop Service, Medical Writing, and Consulting for Drug Development

 

Nonclinical pharmaceutical affairs experts, study directors, and project managers who are experienced Japan and overseas countries offer a one-stop service as scientific monitors.

Staff experienced with the preparation of investigator's brochures(IB) and CTD or experienced study direcrors offer medical writing as scientific writers.

Sciencetific monitor or writers are able to consult on various matters according to your needs.

 

由經驗豐富的日本及各國非臨床藥物專家、試驗主持人以及專案管理員，進行監督並提供完整的one-stop 服務。

並由具有撰寫 investigator's brochures(IB)、CTD經驗的人員或經驗豐富的研究人員協助準備需求文件。

這些專業人士可以協助您所想諮詢的各種事項。

Achievements
  • Preparation of the PMDA pre-consultation materials and interview advice meeting materials
  • Translation of package inserts into japanese
  • Preparation of IB(1 and CTD
  • Translation of CTD into Japanese and editing
  • QC of IB and CTD
  • Preparation of responses to querises from regulatory authorities
  • Translation of nonclinical related documents into Japanese
  • Various types of consulting
Consulting
  •  Optimization of necessary nonclinical studies for development and schedule
  •  Evaluation of nonclinical study data and go/no-go decision on drug development
  •  Suggestion of additional study designs to resolve issues
  •  Support of preparation of submission materials to regulatory authorities(IB, CTD, PMDA pre-consultation materials, interview  advice meeting materials, and response to queries from regulatory authorities)
  •  Participation in PMDA pre-consultation and interview advice meetings
Medical Writing

Preparation of IB, PMDA Consultation Materials and New Drug Application Materials

    • Preparation of documents written in Japanese based on nonclinical study data in Japanese/English

 

Japanese-Eanglish Translation and Editing of Nonclinical Documents

    • Translation into Japanese and editing of reports, IB and CTD written in English
    • Translation into English and editing of reports, IB and CTD written in Japanese
One-Stop Service

From conduct of nonclinical studies ro preparation of IB and PMDA Consultation Materials

      • Central management of nonclinical studies(outsourced monitoring)
      • Troubleshooting for nonclinical studies(judgment of necessity of additional studies and study designs)
      • Preparation of nonclinical parts of IB and PMDA consultation materials inJapanese
      • Consulting of assessment of toxicity and pharmacokinetic studiesm go/no-go decision on drug development and PMDA consultation

 

Clinical Study Support

 

Cooperation with a clinical development CRO such as PPD-SNBL