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2021-09-06 13:34:37 來源：源資信息科技（上海）有限公司
On 6th September 2021, Tri-I Biotech (Shanghai) Ltd. (referred to as Tri-I) and Shanghai TDV Pharmaceutical Consulting Co. Ltd.（referred to as TDV）reached strategic cooperation which will leverage each other’s strengths in the life science industry and deliver further professional informatics support and GxP consultancy service!
In post-COVID19, China domestic healthcare policy is becoming more mature, and the part China plays in global drug supply chain is growing. The demands of launching in multi-markets to new drugs/vaccines/therapies developing companies is rapidly increasing. It brings a revolution in the compliance aspect of quality and regulatory to existing biopharma companies or new drug start-up enterprises in China.
“Tri-I with more than 10 years experiences on project implantation and validation in China, and we’ve been aware that there’s a gap between the existing systems of China enterprises and regulatory compliance.” Said Michael Lee, General manager of Tri-I. “Life sciences companies currently face unique challenges of strict regulatory guidelines and requirements. Therefore, it’s significant to work with a right partner that has a deep understanding and rich experience in pharmaceutical and life science industry.”
TDV總經理Octavi Colomina認為：“TDV有二十多年咨詢全球各市場合規的經驗, 結合源資科技在國內多年智能化信息系統實施落地經驗, 將共同為中國生技制藥行業創造不一樣的知識價值?！?/em>
“ This partnership will provide the best value of the knowledge to China Biotech/Pharmaceutical Industry, through TDV’s extensive experience with global partners with over 20 years and Tri-I’s digital solution implementation experiences.” declared Octavi Colomina, General manager of TDV.
源資科技本著企業初衷, 為成為國內生命科學領域的核心合作伙伴, 已經站在全球藥品市場視野上, 加速國內伙伴不論在企業內的信息化轉型, 智能化系統面的GxP合規之外, 包含自研發GxP到準備各國法規體系審計, 都能給我們的伙伴提供全方位優質的專業服務。今年進入COVID19后疫情時代, 也凸顯了國內制藥企業在全球藥品供應鏈的重要性, 源資科技也將繼續支持我們的伙伴一起共創共榮, 迎來新的產業浪潮。
The intention of establishing Tri-I Biotech is to become a core partner of pharmaceutical and life science companies in Greater China. Tri-I Biotech aims to support clients to step on their digital transformation journey. Tri-I Biotech helps clients to prepare for inspection/auditions in different markets and become GxP compliance on informatics system. 2021 is a post-Covid19 year, it highlights an importance role of domestic pharmaceutical companies in the global pharmaceutical supply chain. Tri-I will continually assist our clients to bring all-wins together in order to welcome the new global industry waving!
TDV 是自1997 年成立的一家專業于 GxP 合規咨詢公司，總部位于西班牙；自 2006 年起通過其當地分支機構在中國上海開展業務。 TDV 為制藥、生物技術、醫療器械或化妝品等各個行業的公司提供質量和合規方面的咨詢服務與良好實踐 (GXP)、驗證、業務流程的數字化轉型以及公司知識管理。
其提供專業的 GxP（GMP、GLP、GCP、GDP）重點項目咨詢：指導企業能有適當質量體系、驗證方法以成功滿足世界各地衛生監管當局（EMA、FDA、NMPA）制定等要求。 此外，TDV 在制藥、醫療器械和生物技術行業及相關行業已擁有 200 多家客戶：服務產業覆蓋原物料 和精工化學品、批發商、實驗室、CRO、軟件開發商等。
TDV is a GxP compliance consulting company with headquarters in Spain since 1997 and operating in ShangHai China through its local affiliate since 2006. TDV advises companies in various sectors – pharmaceutical, biotechnology, medical devices, or cosmetics – in the areas of quality and compliance with good practices (GxP), validation, digital transformation of their processes, and knowledge management in the company.
It provides professional key projects in GxP (GMP, GLP, GCP, GDP) consultancy: have the appropriate quality systems, and validation approach to successfully fulfil the requirements established by the Health Authorities around the world (EMA, FDA, NMPA, etc.). Also, TDV has more than 200 customers in Pharma, Med Device and Biotech industries as well as related industries: API and fine chemicals, wholesalers, laboratories, CROs, software developers, etc
關于源資科技/About Tri-I Biotech
Tri-I Biotech (Shanghai) Ltd. is a leading informatics products and total solutions service provider in China and was founded in May 2008. Tri-I’s goal is to accelerate clients’ development with innovative concepts in the pharmaceutical, chemical and material industry by providing the total solution of AI-enabled computing simulation, big data-based intelligent quality informatics management, and automatic clinical digitalization. Tri-I is continually enlarging its service range, from life science to material science; from implementation, validation service to customized solutions. The success of Tri-I relies on our professional team and their perseverance. Tri-I has continuously brought constructive ideas and contributions to clients in pharmaceutical, chemical engineering, and materials fields.