A robust Quality Management System (QMS) provides a systematic approach to issue resolution and process improvement. RegDev's team of experts collaborate with clients to understand their current QMS needs, identify gaps, provide solutions, and assess effectiveness of existing systems.
RegDev's QMS reviews provide expertise on International Council for Harmonisation (ICH) GCP, European, UK, and US FDA regulatory requirements and trends.
Our QMS services include support in designing and developing robust QMS, SOP and Work Instruction development, Quality Planning, Quality Risk Management, and development of a Root Cause Analysis and Corrective Action and Preventive Action Plan.
Our services also include support in designing and implementing a QMS, providing input on: