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.

view more

 

CRO

  • check

    Needs Discuss

  • check

    Quote and Ordar

  • check

    Timetable Schedule

  • check

    Report Launch

  • done

    Case Closed

view more

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.

有鑑於醫療器材產業的蓬勃發展,由合作夥伴互貴興業主辦的醫療器材系列講座第一站正式開跑。主題環繞著醫材上市為核心,從研發階段至認證申請,環環相扣。

麥德凱很榮幸受邀與各位業界先進分享醫療器材上市前安全性的重要性。期許未來能協助新創產業邁向國際市場。

 

互貴扮推手 助新創團隊勇闖醫材市場

huikui

在這波新冠病毒的衝擊下,經濟活動蕭條,各產業都受到波及,但醫療器材產業反而逆勢上升,因此吸引大量投資者的關注。由互貴興業股份有限公司主辦的醫療器材系列講座「如何開始投入醫療器材的產業」,這次邀請到三位業界專家,麥德凱生科洪志駿博士、康煜生技總經理王莉華(左二)、弘亞生技總經理李憲坤(左四),分別針對醫療器材生命週期所面臨的臨床前試驗、臨床試驗、美國上市申請等議題進行實務分享,引導業者避開產品註冊的死亡山谷。

 

三位講師共同提到醫療器材首重安全與有效,產品從設計開發到上市,需經各種條件測試,確認產品安全有效,有時還要有臨床試驗佐證才算數,待通過各地的法規註冊,產品才能取得銷售資格。互貴興業法規副總蔡子瑛(左一)表示,透過講座能讓新創醫療器材廠商與團隊更了解自己的產品,讓產品上市的過程更順遂。現場業者與講師互動熱絡,成功締造經驗交流的良好學習機會。

 

(新聞連結)