自訂區塊 - MDG麥德凱

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.

CRO

Needs Discuss
Quote and Ordar
Timetable Schedule
Report Launch
Case Closed

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.

自訂區塊

隨著社會高齡化的趨勢及人類生活水準的提升，醫療保健器材的需求日益擴大，為了維護醫療安全與品質，衛生署訂定「醫療器材管理辦法」，所有會接觸人體的醫療器材皆須依照ISO10993國際法規完成「生物相容性試驗」才能申請查驗登記程續。麥德凱擁有TAF及GLP國際品質管理系統及自己獨立的動物實驗中心，為臺灣醫療產業之安全驗測把關。生物實驗室團隊皆熟悉ISO 10993、ASTM及USP生物相容性試驗國際法規，已順利協助國內骨科及牙科植入物、氣切管、血管內輸液套、針筒、隱形眼鏡、手術器械、醫療用布、敷料、醫用導管及耗材、呼吸器等製造商在台灣TFDA、美國FDA(510K)、韓國KFDA及歐盟CE通過查驗登記，提供國內最優質CRO臨床前動物試驗服務。

Copyright © Medgaea Life Science Ltd.

Tel +886-2-2625-3300 Add 7F., No. 45, Ln. 3, Sec. 1, Zhongzheng E. Rd., Tamsui Dist., New Taipei City 351007 , Taiwan (R.O.C.) Email service@medgaea.com.tw

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