QUALITY AND REGULATORY AFFAIRS
Biosearch life as been designed and deployed based on the requirements of ISO 9001, ISO 22000 and GMP (according to ICH Q7 and part II of vol. 4 of Eudralex) and it is continuously monitored and improved by our Quality Assurance Department.
In December 2011, Biosearch life received recognition for its commitment to Quality and Safety via the certification of their systems ISO 9001 and ISO 22000 granted by the Spanish Association of Standardization and Certification (AENOR).
The scope of these certifications includes those processes related to production and distribution of omega-3 oils, probiotics and herbal extracts. Such processes are designed and implemented in order to ensure compliance with client requirements and regulations as well as the continuous improvement of all its activities.
Our organization in the field of quality is divided into three main areas: Laboratories, Quality Assurance and Regulatory Affairs.
The analytical tests required for our products as well as production processes, validations and stability studies are performed in the laboratory area.
Among the available analytical technologies Biosearch Life has HPLC, LC-QQQ-MS, LC-ToF-MS, ICP-MS, FAAS, GFAAS, GC, GC-QQQ-MS (HS)-GC, HPTLC, (RT) -PCR, UV-Vis, microbiology, etc.
Through our Regulatory affairs department we can provide support and advice on regulatory and policy requirements as well as performing all documental tasks which are necessary to respond to our clients.