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ライフサイエンス

ライフサイエンス

Key Contacts

カンボジア

インドネシア

ラオス

ミャンマー

タイ

ベトナム

OVERVIEW

東南アジア諸国の法律家と専門家から構成される当事務所のチームは、ライフサイエンス業界の分野において比類のない法務サービスを提供します。

当事務所のライフ・サイエンス・チームは、経験豊富な弁護士、専門的学位を保有する弁理士、業界経験のある薬剤師等から構成され、医薬品、化粧品、食品・飲料、バイオテクノロジー、医療機器、動物用医薬品等のライフ・サイエンス分野で事業を展開する企業に対して包括的なサービスを提供しています。当事務所のサービスは以下の事項に関連して提供されています。

  • 規制関連   医薬品、バイオテクノロジー製品、食品・サプリメント、鎮痛剤・向精神剤、医療機器、化粧品、有害物質、家畜用飼料、健康食品等について、各国の食品・医薬品規制機関・農作物規制機関等において知的財産権の登録及び関連業務を遂行します。
  • 企業法務及び取引関係   会社設立、クロスボーダー取引、労働・雇用、デューデリジェンス、コンプライアンス、知的財産関連評価・ライセンス、譲渡・買収、フランチャイズ、販売代理店、技術移転、税務・関税等の分野においてアドバイス及び法務サービスを提供しております。
  • 知的財産権の登録   知的財産権調査、登録、Freedom-to-Operateの意見書、申請、遂行を含む、特許・商標・企業秘密・著作権・地理的表示についての戦略的ポートフォリオ管理をサポートいたします。
  • 知的財産権の確保と訴訟.   訴訟前の協議・仲裁、知的財産関連訴訟の戦略・遂行、知的財産権の無効申し立て、製造物責任、消費者からの申立、リコール、市場及び申請段階における侵害製品の監視などについてアドバイス及び法務サービスを提供いたします。

Experience

  • Acted as counsel to a major pharmaceutical company by liaising with the Thai FDA on marketing compliance issues, verifying that the client’s marketing activities were in compliance with the complex regulations governing pharmaceutical practice in Thailand, and preventing and mitigating risk and loss.
  • Helped a multinational food company comply with Thai FDA requirements. Advised the client on advertising and promotional materials in Thailand, with particular emphasis on the requirements of the FDA and the consequences of improper ad content.
  • Acted on behalf of a major U.S.-based agrichemical manufacturer. The case involved termination of the client’s distributor for breach of contract and IP (patent and trademark) infringement. In addition, we represented the client in re-registration of its full range of products with the Thai Ministry of Agriculture.
  • Negotiated with the Thai FDA to reclassify a client’s drug product from a new chemical entity (NCE) to new combination (NCO) and secured the successful registration of this product.
  • Answered a critical client inquiry on whether their products could be imported without a certificate of formula disclosure provided to the Customs officer.
  • Secured an export license for the client in an efficient manner, as required by the head of the product group.
  • Coordinated the actions of multiple parties (the reviewers in Thailand, the foreign regulatory affairs authority, and the firm) to timely secure a pharmaceutical product license for the client.
  • Helped an Italian pharmaceutical company prepare an application dossier and obtain a license to operate in the area of medicinal products.
  • Handled a portfolio of products of a pharmaceutical client.  Our representation included assisting in the registration of the products, reviewing and advising on product labels, and assisting in transferring the products to a third company.
  • Secured medical device registration for a top shoe manufacturer and trader in Thailand by giving beneficial advice to the client and working closely with the client to resolve issues with its application.
  • Registered, in a seamless and efficient manner, a cosmetic product for a large importer in a limited period of time, which enabled the client to timely launch the product.
  • Advised a global pharmaceutical company on all aspects of doing business in Vietnam, including the formation and operation of a representative office, registration as a foreign pharmaceutical company, property transactions, and employment termination and labor disciplinary procedures.

弁護士・専門家

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