We are consultants focusing on Quality- / Risk- / Compliance-Management and Regulatory Affairs with longstanding experience in the pharmaceutical, life science-, chemical- and medical device industry. As a team we support these industries with best practice and individualized solutions for your projects. Our consulting mojo is based on proficiency in multiple sectors, like Quality Management (AMG/AMWHV, EudraLex, ICH Q10, ISO 9000/9001, ISO 13485, ...), Risk Management (ISO 14791), Computer System Validation (CSV) incl. Data Integrity (ISPE GAMP 5.2 / ASTM 2500), Program & Project Management and Implementation, support and maintenance of Manufacturing Execution Systems (MES). Your challenge is our passion! We attend to your challenges and address them objectively and with the experience gained during many previous customer projects. Our counsel is competent and independent, so you can rely on our expert advice and guidance.