About
MDG

Medgaea Life Sciences is a third party laboratory that is certificated for OECD GLP, TFDA GLP, ISO 17025 and ISO 9001. Maily based on preclinical CRO, we provide total-soltion services to assist biotechnology industries successfully obtain the product certification and exploit internation market.

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CRO

  • check

    Needs Discuss

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    Quote and Ordar

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    Timetable Schedule

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    Report Launch

  • done

    Case Closed

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Services

With devoting to our core value 『Honesty•Accuracy•Professionalism•Responsibility』,

We have successfully assisted our customers to successfully obtain the product certification in FDA, CE, TFDA and NMPA.

Medical Devices

One of the first priority of medical devices R&D is their safety. The Biocompatibility test is mainly followed the ISO 10993 international standard.

Cell therapy and Regenerative medicine

We assist the safety, effectiveness tests during the R&D process of cell therapy product. All the tests are complied with GLP.

Pharmaceutical development

As the agent of SNBL in Taiwan, will help new drugs company to complete non-clinical trials in medium, large animals and primates in the research and development stage.

Agrochemical and Enviromental Agents

The agroculture products need to review their toxicological data in advance, and all the tests must be carried out in complies with GLP.

Chemical Substances

Providing the toxicological test information!
EPA acquired the test information as the core basis to evaluate the substance announcement.

Health Food/ Ingredients

Provide safety, efficacy and stability tests for food ingredients and health foods.

Registration

Provide registration services.

Pharmaceuticals

Provide batch examine for medicine release, including pyrogen, acute systemic toxicity and other tests.

Laboratory animals and Equipment

An agent and supplier based on research and development of animal experiments, providing import services for various disease model animals in research institutions.

發文日期:中華民國110年9月15日

發文字號:衛授食字第1111300075號

 

附件

以基因改造畢赤酵母菌Ey72菌株發酵生產之食品原料小孢子靈芝類球蛋白濃縮液之使用限制及標示規定

 

主旨

訂定「以基因改造畢赤酵母菌(Pichia pastoris) Ey72菌株發酵生產之食品原料小孢子靈芝類球蛋白濃縮液(Ganoderma microsporum globulin-like protein concentrate)之使用限制及標示規定」,並自即日生效。

 

依據

「食品安全衛生管理法」第十五條之一第二項及第二十二條第一項第十款

 

公告事項

訂定「以基因改造畢赤酵母菌(Pichia pastoris) Ey72菌株發酵生產之食品原料小孢子靈芝類球蛋白濃縮液(Ganoderma microsporum globulin-like protein concentrate)之使用限制及標示規定」/p>

 

 

檔案下載
1111300075-公告掃描檔(111.2.16公告)
1111300075-公告規定(111.2.16公告)

 

相關連結
本署新聞-公告訂定「以基因改造畢赤酵母菌(Pichia pastoris) Ey72菌株發酵生產之食品原料小孢子靈芝類球蛋白濃縮液(Ganoderma micro-sporum globulin-like protein concentrate)之使用限制及標示規定」