Building Tomorrow’s FDA/EMA Compliant Intelligent Enterprise Solution

by Brian Freymann, Director, Enterprise Solutions The core issue that drives compliant solutions is that drug, medical device, and instrumentation companies are monitored closely by the FDA/EMA. The regulatory requirements are designed for the purpose of managing all data that has an impact on patient safety. Both the FDA’s Title …

Quality Risk Management

Quality Risk management (QRM) is a systematic process for the assessment, control, communication, and review of risks to quality of the drug product across the product lifecycle. The approach to managing risk is established via an evaluation of risk to quality. The evaluation is based on scientific knowledge and ultimately …

Good Clinical Practice Compliance Solutions

Practical Hands-On Experience Kymanox has a diverse body of work, practice, and professional experience – exclusively focused on the life sciences. We understand your business in a way that translates into collaborative, cost-effective solutions. We provide: • Clinical Quality Management System Development and Optimization • Clinical Compliance Gap Assessments • …