面对COVID19后疫情时代，中国健康医疗法规政策更趋向成熟及全球药品供应链新药、疫苗与新疗法研发及出口至多国市场等需求，这对国内既存医药公司或新药创业型公司来说，无疑是一场需要快速提升合规质量与法规的变革。
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.
“源资科技拥有十多年智能化信息服务落地实施与验证经验, 深刻了解国内企业在原先体制与面对审计合规之间的落差”，源资科技总经理李旻熹先生表示：“生命科学公司面临着严格的监管要求等挑战，因此同时也需要对其行业具有深刻理解和业务经验的合作伙伴。”
“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总经理Octavi Colomina认为：“TDV有二十多年咨询全球各市场合规的经验, 结合源资科技在国内多年智能化信息系统实施落地经验, 将共同为中国生技制药行业创造不一样的知识价值。”
“ 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.
源资科技本着企业初衷, 为成为国内生命科学领域的核心合作伙伴, 已经站在全球药品市场视野上, 加速国内伙伴不论在企业内的信息化转型, 智能化系统面的GxP合规之外, 包含自研发GxP到准备各国法规体系审计, 都能给我们的伙伴提供全方位优质的专业服务。今年进入COVID19后疫情时代, 也凸显了国内制药企业在全球药品供应链的重要性, 源资科技也将继续支持我们的伙伴一起共创共荣, 迎来新的产业浪潮。
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!
关于TDV/About TDV
TDV 是自1997 年成立的一家专业于 GxP 合规咨询公司，总部位于西班牙；自 2006 年起通过其当地分支机构在中国上海开展业务。 TDV 为制药、生物技术、医疗器械或化妆品等各个行业的公司提供质量和合规方面的咨询服务与良好实践 (GXP)、验证、业务流程的数字化转型以及公司知识管理。
其提供专业的 GxP（GMP、GLP、GCP、GDP）重点项目咨询：指导企业能有适当质量体系、验证方法以成功满足世界各地卫生监管当局（EMA、FDA、NMPA）制定等要求。 此外，TDV 在制药、医疗器械和生物技术行业及相关行业已拥有 200 多家客户：服务产业覆盖原物料 和精工化学品、批发商、实验室、CRO、软件开发商等。
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
关于源资科技/About Tri-I Biotech
源资信息科技（上海）有限公司是中国先进的信息化产品和整体解决方案服务供应商，成立于2008年5月。源资科技的目标是以提供AI计算模拟、基于大数据的智能质量信息管理和自动化临床电子化等创新理念提供的整体解决方案，加速各客户在制药、化工和材料领域的发展。源资科技正不断扩大其服务范围，从生命科学到材料科学，从实施、验证服务到定制开发。源资科技的成功取决于专业团队和他们不懈精神并不断为客户带来建设性的想法和贡献。
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.
