We offer you substantiated knowledge and concrete experiences in the implementation of current requirements of EMA, FDA and Swissmedic within the realms of GCP, GDP and GMP.
Together with you we develop customized solutions, considering your internal strategies and standards.
Our consultants work with initiative and efficient methods as well as with distinct solution driven, analytical and systemic approaches.
Our services comprise the following subject areas:
• Quality Management System (ICH Q10, ISO 9001)
• Process Management (ISO 9001)
• Computerized System Validation (Annex 11, 21 CFR Part 11)
• Risk Management (ICH Q9, ONR 49001, COSO ERM)
• IT Service Management (ITIL, ITSM)
• Information Security (ISO 27001)