A Quality Management System (QMS) is a crucial 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 necessary procedures and policies aligned with industry best practices and regulatory standards.
Our team of experts can support the design and implementation of a robust Quality Management System (QMS) for your organization!
We will work closely with you to understand your specific needs and challenges to ensure rigorous compliance with all necessary policies, processes, and procedures essential for both planning and executing the production and development 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 and implementation of stability programs
- Support in preparation for annual product reviews
- Management of product recalls
- Handling of complaints
- Master Production Documentation review
