SOTAX
SOTAX創建于1973年,起初為制藥企業和相關工業提供工程設計服務,隨即專注于藥物溶出度儀器的研發和推廣。如今SOTAX已成為開發和生產片劑測試儀器的全球領導者以及為制藥工業研發及檢測解決方案的提供者。
我們的管理層始終專注于公司在所有的運作層面上保持最高質量的水準,并持續改進質量體系以滿足GMP,GAMP和ISO 9000-3的要求。在 1996年,SOTAX通過了ISO 9001質量認證,并在1999年獲得了有關軟件研發的 TickIT質量體系認證。因此成為世界首家通過這一認可的溶出度系統供應商。
SOTAX的所有儀器均滿足USP, EP, FDA, FI 和CHP的指南,大部分產品也都滿足 FDA 21 CFR Part 11法案的要求。
SOTAX作為研發尖端精密的測試設備和自動化系統的專家,建立起了卓越的國際聲譽。我們與世界的主要制藥企業一起合作開發為企業定制的軟硬件解決方案為其產品。
SOTAX公司已于2008年并購了美國Zymark?品牌,進一步鞏固了其作為全球首屈一指的溶出度及片劑自動化測定系統提供者的領先地位。
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.