We help you solve
business "problems"


Animal health consulting


Product development and regulatory/legal compliance
  • 新製品開発についての調査、海外資料の精査(GAP分析)
  • 新動物用医薬品、医療機器等の承認申請のお手伝い
  • 国内企業の本社ならびに製造所移転に関する業務
  • GMPに関する研修と薬事サポート
  • コンプライアンスに関する社員教育
  • 海外提携先とのコミュニケーションサポート
  • Investigation of overseas documents to compare with Japanese requirement (GAP analysis)
  • Support to obtain licenses of the new products for Japanese market.
  • Support for getting licenses for manufacturing veterinary medicinal products.
  • Compliance and GXPs training.
  • Support communication between overseas companies and Japanese agents.

Technical writing

Support for preparing various documents
  • 一般薬、ワクチン、バイオ医薬品などを含む新動物用医薬品の承認申請に必要な書類の作成
  • 製造販売業、製造業の許可申請、海外製造者認定などの資料作成
  • 既存製品の事項変更承認申請書、軽微変更届書などの作成
  • 既存製品の有害事象報告書作成、使用成績調査、文献調査
  • コンプライアンスに関する社内研修やSOPの作成
  • VICHなど各種ガイドラインの翻訳
  • 海外研修用ならびに販促用資料の翻訳
  • Prepare various documents for getting or maintenance of product sales approval.
  • Prepare SOPs and training documents for private companies.
  • Translation of VICH guidelines.
  • Translation of various technical documents or promotional material.


We have only limited number of staffs with high quality and experiences.
Specialists for biologicals, biopharma, regulatory/legal matters and with clinical experiences are ready for your support.
They are highly appreciated from clients including global and domestic companies.


If you have any queries about our services please contact us.

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