You are building up a new biotech company and you have to implement your quality management system (QMS)? You are an academic group or team conducting clinical trials as a sponsor – investigator? You are a clinical research excellence center or network of excellence? We may assist you in developing and implementing your quality management system including the writing of client specific standard operating procedures (SOPs) according to regulatory requirements.
Do you suspect having gaps or limitations in your quality management system (QMS) which prevent you from being regulation compliant or efficient? Is your daily business hampered by a too large number of SOPs? An external view may improve your QMS. We offer to assess your QMS regarding its compliance, efficacy and effectiveness and assess the effectiveness of your internal staff training.