A Quality Management System (QMS) is acrucial regulatory requirement mandated by the FDA, Health Canada, and other global regulatory bodies. Taking into account your organization's structure, size, and stage of development, we offer assistance in developing, optimizing,and overseeing your GMP quality system. Our services include crafting necessaryprocedures and policies aligned with industry best practices and regulatory standards.
Our team of experts can support the designand implementation of a robust Quality Management System (QMS) for your organization!
We will work closely with you to understand your specific needs and challengesto ensure rigorous compliance with all necessary policies, processes, andprocedures essential for both planning and executing the production anddevelopment of your products.
We will provide expert guidance on:
- Establish new QMS or assess the state of an existing one
- Gap assessments and remediation plans
- Writing and reviewing Standard Operating Procedures (SOPs)
- Preparation for audits and inspections, and management of inspection-readiness programs
- Reviewing and facilitating Management Review process and provide recommendations for improvement
- Deviation and CAPA management
- Risk Management
- Design andimplementation of stability programs
- Support inpreparation for annual product reviews
- Managementof product recalls
- Handling of complaints
- Master Production Documentation review
