Quality Management Consulting Services for Compounding facilities
Unlock potential with exceptional quality management systems through our consulting services that emphasize quality assurance.
About 503 Quality Consultants LLC
Our Vision
Our Approach
Our Approach
Our vision at 503 Quality Consultants LLC is to be the leading provider of exceptional quality management systems within the Pharmaceutical Compounding industry. We aim to achieve this by continuously improving our quality assurance processes, investing in our people, expanding our knowledge, and leveraging technology to deliver innovative solutions to our clients.
Our Approach
Our Approach
Our Approach
At 503 Quality Consultants LLC, we take a customized approach to each client engagement through our expert consulting services. We work closely with our clients to understand their unique needs and develop tailored quality management solutions that deliver results. Our approach is collaborative, responsive, and focused on providing quality assurance to ensure value for our clients.
Empowering Your Business
Strategic Planning
Our consulting services for quality management assist Outsourcing facilities (503B), Compounding Pharmacies (503A), and Physician's offices that compound in defining their goals and creating actionable plans to achieve them. We believe that a robust quality assurance system is the cornerstone of sustainable growth.
Our services include but are not limited to:
- Provide on-site audits to evaluate current quality management systems.
- Conduct assessments of any regulatory correspondence, such as a 483 or a warning letter from the FDA, to facilitate resolution and enhance quality assurance.
- Perform root cause analysis in instances of deviations and out-of-specification outcomes & develop a comprehensive CAPA plan.
- Create, review, and revise Standard Operating Procedures (SOPs) to align with quality management principles & regulatory compliance.
- Offer training and education within the facility on key elements of a sound cGMP and USP compliant quality system, customized to the facility's business model.
- Provide consulting services to 503A compounding pharmacies regarding disciplinary actions on compounding operations.
- Offer pharmacist consulting services to Ambulatory Surgical Services and Health Care Systems.
- Offer audit services to compounding facilities for supplier and third-party verifications.
- Provide consulting services to facilitate the transition from a 503A to a 503B.
- Offer consulting services to establish, operate, and manage a new compounding facility in the state of California.