Looking for a development/manufacturing partner?

  • 1. Which do you want to outsource, an IVD or RUO product?
  • 2. Are you looking for a contract developer, or a contract manufacturer?
  • 3. What kind of product do you want to oursource? ELISA, LATEX, IC, or something else?

Advantages of Our Contract Development and Manufacturing

  • We are capable of contract manufacturing for IVD products in Japan.

    • - We are licensed to manufacture IVD products in Japan and are ISO 13485 certified.
    • - We are able to provide design development of your IVD product and support your application for marketing approval.

  • We are also capable of contract manufacturing in RUO products.

    • - We accept contract manufacturing requests from companies in various industries, such as food product manufacturers.

  • If you have already established a system and have basic information on the product specifications, we can start the manufacturing process from the production transfer stage.

  • If you don't have an antibody, we can produce one for you.

  • Process validation is available upon your request.

Our Manufacturing Base

Tochigi Plant
170, Shimoishibashi, Shimotsuke-shi, Tochigi-ken 329-0512 Japan

Registration Certificate as an IVD Manufacturer in Japan

Certificate of Registration - ISO 13485:2016
(Original Registration Date: August 11, 2015)

Manufacturing Facilities at Tochigi Plant

  • Tochigi Factory Introduction Video
    (3 minutes)

  • Air shower at the entrance

  • Raw material storage

  • Digital scale with printer

  • Scale for mixing reagents

  • Ultrapure water production system

  • Tabletop liquid-filling system

  • Weight checker

  • Automatic plate washer

  • Drying room

  • Vacuum freeze dryer

  • Material warehouse

  • Auto labeling system

  • Cold storage for semi-finished products

  • Microplate reader

  • Incubator

  • HPLC analysis system

Outsourcing Workflow

  • １.　Inquiry
  • ２.　1st meeting
  • ３.　NDA conclusion
  • ４.　Plant tour, followed by 2nd meeting