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生科春燕先知─麥德凱為產品安全把關 麥德凱生科 2019-08-08
 
生科春燕先知Test locally, succeed globally
 
麥德凱為產品安全把關
MDG will Help You Meet The Regulatory Requirements
 
亞洲生計大展 展會快訊/版11
 
  隨著近年生科題材多元化,臺灣市場和國際市場皆致力於取得跨國資源,佈建國際產業,除了再生醫療議題,其涵括「免疫療法」、「細胞治療」和「基因療法」,還有新/既有化學品產業一直以來是台灣製造業的支持與發展主力,且近年蓬勃發展,其它保健食品、醫療器材和藥品等產業產值持續穩健成長,而麥德凱生科亦跟隨客戶衝刺前景,全力協助相關企業完備相關認證與國際標準接軌。
  麥德凱生科擁有TAF 及GLP 雙認證動物實驗中心,集結超過10 年臨床前試驗經驗的博士級試驗主持人及獸醫師,對試驗人員資格嚴格把關,秉持專業的態度與實驗技術,提供細胞治療產品、保健食品、醫療器材、藥品與新/ 既有化學品等臨床前試驗服務,除了提供專業法規諮詢服務協助客戶解決產品製程上遇到的問題,也規劃最有效率的試驗排程幫助客戶在最短的時間內完成產品的查驗登記,客戶包含歐、美、中、日等國際大型企業,每年為台灣及國際企業完成數百本的安全性認證需求報告。


Due to the increasing size of the aging population and elevated living stan­dard, the demand for medical services has been significantly increasing. To en­sure the safety and quality for medical treatments, MedGaea (MDG) provides pre-clinical testing service, including, medical devices, biomedical materials, health foods, pharmaceutical products, herbal medicine, cell therapy products, and chemicals.
MDG is a fair, non-biased third party for biotechnology product testing/ac­creditation. MDG follows core values such as, "Honesty, Accuracy, Professional­ism, and Responsibility" to achieve the business goals. MDG supplies domestic and international CRO services to connect R&D, commercialization, and manu­facturing chain in the biotechnology industry; such as:
(1) Designing customized project plans to add value to biotechnology products and techniques
(2) Assisting the application of product accreditation (e.g. Taiwan FDA, US FDA, EU CE and so on)
(3) Exploring the global market for biotechnology products and techniques.
Clients from Europe, USA, China, and Japan recognize MDG as a premier provider of safety assessment and discovery services to the health ingredient, biotechnology, medical device, and chemical industries worldwide.
Based on specific needs from the clients, MDG's ISO 17025 and GLP certi­fied laboratory and animal facility are able to provide customized research plans and protocols with timesaving and accurate research techniques. Also, MDG offers reliable and cost-efficient pre-clinical animal testing services to assist cli­ents in shortening the timeline to launch new drugs and products into the market. As for helping the clients to register, MDG´s study directors are professional in replying to inquiries about regulatory issues.
Last year, MDG and SNBL (Shin Nip­pon Biomedical Laboratories, Ltd.) signed an MoU (Memorandum of Understanding) to make a biotechnology chain. SNBL was founded in Kagoshima as Japan's first con­tract research organization in 1957 and larg­est pre-clinical facility allows flexibility to ac­commodate a wide variety of products and study types. SNBL has abundant experienc­es and knowledge on Non-Human Primates (NHPs). As a result of the cooperation, MDG and SNBL have had several successful cases in Taiwan thus far.