The Quality Assurance & Registration Affairs Department (QARAD) is our technical service department; it concentrates in providing “high quality, standardized, professional and prompt” consulting services. The QARAD helps our clients in application of COS and EDMF, ensuring that they can get COS or EDMF quickly and successfully. As the new legislation “REACH” (Registration, Evaluation and Authorisation of CHemicals) has been passed, we offer from now on the agent service of REACH and its relative consulting services.
The Quality & Registration Department has a professional team: they are familiar with both Chinese and European pharmacy administration system; they are familiar to pharmacy production and quality management; they are versed both in English and French; and they have been engaged in technical consulting services about pharmaceutical products for many years. What's more, the Quality & Registration Department has a laboratory center in Sichuan University , and has a long term's relationship with European pharmaceutics experts; all of these effectively ensure the authority of our consulting services. Since we began the registration services in 1999 to now, we have already applied COS registration for many Chinese API manufacturers and have obtained 10 COS successfully; we also have compiled many EDMF for our European clients, which are in the following procedure nowadays, involving fermentation products, semi-synthetic and synthetic products, etc.
Our consulting services include:
• Agent of application for Certificate of Suitability (COS/CEP), edition of COS files;
• Compilation of European Drug Master File (EDMF);
• We offer agent service of REACH (Registration, Evaluation and Authorisation of CHemicals) and its relative consulting services;
• GMP Simulation audit for API manufacturers;
BIMSIFRAM Analytical Laboratory services (GLP):
• Drug examination
• Research and identification of impurities involved in COS/EDMF
• Preparation, separation and identification of Reference Standards (RS)
Our Quality & Registration Department will always provide “high quality, standardized, professional and fast” consulting services to pharmaceutical companies from all over the world.