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Employer Integrated Development Associates Co., Ltd.

Company Name Integrated Development Associates Co., Ltd.
Country of Company HQ Japan
Location of Company Japan
Company Intro
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Integrated Development Associates Co., Ltd. (“IDA”) is a Tokyo-based consultancy that assists biopharmaceutical companies increase the value of their products by integrating Japan and Asia into global drug development. Since 2004 IDA has assisted more than 40 client companies with development strategies, KOL advocacy, PMDA consultations, implementation of trials, Orphan Drug applications, J-NDA submissions and licensing negotiations. Our bilingual team of 10 consultants combines strategic, scientific, regulatory, project and clinical operations expertise.


株式会社Integrated Development Associates （以下、”株式会社IDA “）は、日本及びアジアでの最適な融合化を通じ、バイオ医薬品企業がグローバル医薬品開発において自社製品の有用性を強めるための支援サービスを提供する、東京に拠点を置くコンサルティング会社です。2004年以来、株式会社IDA は40社以上の製薬会社を支援し、ブリッジング開発プログラムの実施、グローバル試験に日本を統合・取得、オーファンドラッグの指定、日本で成功したパートナー製品の維持を可能にしてきました。
Industry Consulting - Other
Location 東京都渋谷区神泉町10-10　神泉ビル3A
President John Winebarger
Year of Establishment 2004
Capital N/A
Number of Employees N/A
Description of Business IDA assists clients with:

・Defining the optimal medical positioning of products in Japan.
・Preparing drug development strategies to achieve optimal product profile.
・Developing KOL advocacy for compounds and development strategies.
・Gaining formal PMDA endorsement of regulatory pathways to approval.
・Enabling integration of Japan into global trials.
・Managing implementation of Japanese trials as a Clinical Trial In-Country Caretaker ("CT-ICC").
・Managing preparation and submission of Orphan Drug and J-NDA submissions as a Designated Marketing Authorization Holder("D-MAH").
・Identification of and negotiations with licensing partners.


IDAが提供するサービス:

・日本医療において製品の最適な位置付けの定義
・最適な製品プロファイルを達成するための薬剤開発戦略の作成
・化合物や開発戦略のためのKOLによる擁護手配
・PMDA当局から開発プランにおける正式な承認獲得
・グローバル試験における日本の統合を可能化
・選任製造販売業者（”D-MAH”）として、オーファンドラッグおよびJ-NDAの準備と提出を管理
・ライセンスパートナーとの交渉
URL http://i-d-a.com
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