About Us

FDA certification opens the door to the world!"

a fine thing to say (used as part of a sarcastic response to a rude remark)

Hello everyone.

I am Charles Cho, Japan Regional Manager of AK SCIENCE RESEARCH INTERNATIONAL CO., an FDA-registered laboratory based in the United States.

AK SCIENCE RESEARCH INTERNATIONAL CO. Japan Branch is a research institute that, in addition to its regular FDA duties, analyzes and determines whether various food products, drugs, medical devices, and cosmetics in circulation comply with the U.S. Food and Drug Administration (FDA) standards.

The Asian Branch was established in Korea in 1996 and has been faithfully carrying out its duties up to the present. Companies considering exporting or entrepreneurs wishing to expand their products internationally are encouraged to take advantage of our long-standing experience and proven track record in the laboratory. We sincerely hope that through ensuring the safety of your products and efficient production, distribution, and sales, you will gain international trust and make further progress.

Your product, the fruit of your blood, sweat, and hard work, is already open to the global marketplace upon completion of FDA inspection and registration.

AK Science Research International Co.
Seongduk Cho, President, FDA Japan, Inc.


会社概要

社名FDA Japan Inc.
創業平成27年6月15日
資本金2,000万円
本店東京都中央区日本橋本町四丁目7番2号 ニュー小林ビル3F
代表取締役趙 成得
Duties1. 米国連邦食品医薬品局(FDA)の代行検査・登録業務
2. FDAの代行機関として、食品・医薬品・化粧品等を米国連邦食品医薬品局に適用しているのかを分析・判定する業務代行
3. FDA等に関する各種セミナー・講習会等の企画並びに開催による普及・啓蒙活動
4. FDA等に関する書籍、雑誌、映像媒体等の企画、編集、出版並びに販売
5. FDA等に関する総合コンサルティング業務
6. 医療機器、健康機器、美容機器、健康補助食品、化粧品等に関するコンサルティング
7. 化学薬品・化学工業薬品・農薬・肥料・食品添加剤の製造、製造販売、販 売、輸出および輸入に関するコンサルティング業務

Access

FDA Japan K.K. 4-7-2 Nihonbashi-Honcho, Chuo-ku, Tokyo 103-0023, Japan (New Kobayashi Building 3F)

組織図


AK Science Research International Co.について

FDA(米国食品医薬品局)認定の弊社関連会社の研究所での検査を受けることで、御社の製品は米国市場進出への重要な関門を通過したことになります。

米国進出に際し、以下の製品に関する検査は弊社までご依頼ください:

  • foodstuff
  • Medical supplies
  • cosmetics
  • medical equipment
  • chemicals
  • mineral water
  • pesticide
  • Plastics and new materials
  • health foods
  • pesticide residue
  • environmental pollutant

■Inspection organization

  • FDA Laboratory Services International, Inc.
  • Laboratory Services International, Inc.
  • Institute for Pharmaceutical and Environmental Analysis
  • North American Science Associates, Inc.
  • Irvine Analytical Laboratory (California State Certified Laboratory)

Located near Los Angeles, California, USA, we are an FDA-commissioned laboratory that analyzes and determines whether foods, drugs, cosmetics, and other products comply with U.S. Food and Drug Administration standards. The laboratory plays a key role in FDA's registered research activities and in the analytical evaluation of the quality of all applicable products regulated by the FDA.

For products sold in the U.S. and imported products, we conduct quality evaluations based on the same standards as for domestic products, and we conduct conformity audits in accordance with FDA standards. Therefore, the FDA is an indispensable organization for companies considering exporting to the U.S. and for Japanese companies considering internationalization of their products for global expansion.

Having your products certified to FDA standards by our laboratory will further enhance the credibility of your company and its products.


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