At SAGE, we maintain up-to-date knowledge of the standards and requirements provided by regulating bodies such as FDA, Health Canada, etc. We are able to apply current regulations in the following areas:
• IQ / OQ / PQ
• Design for GMP and Gap Analysis
• Lab Validation
• Computer System Validation
• Risk and Criticality Assessment
• Procedures and Policies
• Auditing and Audit Reponses
• Documentation Preparation and Execution
