serach

   Honesty•Accuracy

Professionalism•Responsibility

   Honesty•Accuracy

Professionalism•Responsibility

Honesty•Accuracy•Professionalism•Responsibility

Core Value

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

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    Needs Discuss

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    Quote and Ordar

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    Timetable Schedule

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    Report Launch

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    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.

助攻臺灣新藥開發臨床前研究麥德凱取得SNBL臺灣代理

麥德凱生科股份有限公司(MDG)宣布已於10月與日本最具規模的非臨床試驗公司新日本科學株式會社(SNBL)攜手合作，取得臺灣正式代理權，將助力臺灣新藥於研發階段取得中、大型動物及靈長類非臨床試驗，並為打入日本市場提供利基，促進臺灣生技新藥臨床前開發。此為國內外CRO聯合提供非臨床試驗服務的首個成功模式。

MDG與SNBL於2018年8月於日本東京簽訂合作意向書迄今已有1年時間，期間成功協助4件國內研發計畫於SNBL進行非臨床試驗，為此雙方建立良好的信賴關係，今年2019年10月SNBL簽訂MDG為臺灣正式代理，負責其在臺對客戶的溝通及專業協助。

麥德凱總經理洪志駿表示，臺灣生技製藥產業蓬勃發展，但長期以來在研發階段因取得中、大型動物及靈長類非臨床試驗不易，常導致研發時程延宕並且耗費不貲。SNBL對於新藥研發深具豐富經驗與專業知識，偕同MDG專業團隊支援英日文溝通，在每次試驗執行前與客戶進行協同會議並且深度討論，不僅可避免執行不必要的試驗，更可降低客戶開發風險，加速研發進程節省經費。

此次，國內外CRO聯合提供非臨床試驗服務，在國內屬第一個成功模式，期待專業與專業的聯合能推動來國內新藥產業加速產品上市，並開拓歐美日市場。

SNBL新日本科學成立於1957年，為日本最具規模的新藥及生物製藥等項目的非臨床CRO研究中心。其取得日本PMDA GLP，並可同時符合FDA GLP 及OECD GLP之規範，專長於中大型動物與靈長類非臨床試驗，過去5年間即執行完成超過2000項次生物醫藥品及再生醫療製品評估實績，於美國、亞洲等地擁有據點、提供全球性的醫藥品開發服務。

代理公告同步公布於SNBL新日本科學官方網站：https://www.snbl.co.jp/cat_business/4638/