SOTAX
SOTAX创建于1973年,起初为制药企业和相关工业提供工程设计服务,随即专注于药物溶出度仪器的研发和推广。如今SOTAX已成为开发和生产片剂测试仪器的全球领导者以及为制药工业研发及检测解决方案的提供者。
我们的管理层始终专注于公司在所有的运作层面上保持最高质量的水准,并持续改进质量体系以满足GMP,GAMP和ISO 9000-3的要求。在 1996年,SOTAX通过了ISO 9001质量认证,并在1999年获得了有关软件研发的 TickIT质量体系认证。因此成为世界首家通过这一认可的溶出度系统供应商。
SOTAX的所有仪器均满足USP, EP, FDA, FI 和CHP的指南,大部分产品也都满足 FDA 21 CFR Part 11法案的要求。
SOTAX作为研发尖端精密的测试设备和自动化系统的专家,建立起了卓越的国际声誉。我们与世界的主要制药企业一起合作开发为企业定制的软硬件解决方案为其产品。
SOTAX公司已于2008年并购了美国Zymark®品牌,进一步巩固了其作为全球首屈一指的溶出度及片剂自动化测定系统提供者的领先地位。
SOTAX, founded in 1973, began as an engineering company to service the pharmaceutical and other industries.
Today SOTAX is a leader in the development and manufacturing of test instruments and software for tablet testing and is a leading solution provider for the pharmaceutical industry. SOTAX is owned privately by the Benz family.
Our management focuses on very high quality standards in all operation levels and is continuously improving the quality of its systems to meet GMP, GAMP and ISO 9000-3 standards. In 1996 SOTAX received the ISO 9001 Certification, extended in 1999 to the TickIT Quality system for software development, thereby becoming the world’s first supplier of dissolution testing systems to receive this seal of quality. SOTAX instruments meet all USP, EP, FDA, FIP guidelines and most SOTAX products are in compliance with 21 CFR Part 11.
SOTAX has established an excellent international reputation as a specialist in the development and production of sophisticated test equipment and automated systems. We work with major pharmaceutical companies to develop customized hardware / software solutions for their products.
Worldwide, SOTAX has a staff of skilled and motivated employees. Its headquarter is in Allschwil, near Basel, the center of the pharmaceutical industry in Switzerland: manufacturing, engineering, research and development, as well as administration, sales and marketing departments are all located there together with a demo and application laboratory as well as an auditorium for conferences and seminars.
SOTAX has sales and service organizations in Canada, France, Germany, Great Britain, Italy, Switzerland, China, India and USA and is represented in other markets through local distributors. The US organization is located in Westborough, Massachusetts, with administration, demo and application laboratory, maintenance center and warehouse. SOTAX Corporation has a network of sales and service specialists throughout Canada and the USA.
SOTAX also offers its know-how as a service to the pharmaceutical industry, including installations, maintenance and repair services as well as a comprehensive and careful validation service in compliance with FDA regulations.
The loyalty displayed by our regular customers in more than 40 countries throughout the world encourages us to continue to deliver the highest quality.