COMPLIANCE AND QUALITY SYSTEMS
Clinical Research Consultants stands committed to helping clients find the most effective, cost-effective method for achieving their quality goals and regulatory compliance. Because we work with our clients through all stages of product development, we have developed working relationships with recognized experts who can design, assess, and implement the best systems, procedures, and documentation needed to meet US FDA, GMP, and GLP regulations, and ISO standards.
Developing and Implementing Quality Systems
Quality system assessments and compliance audits
Corrective/preventive action programs
Pre-production quality assurance and design control
Document and process validation
Product and process validation
Software quality assurance, including validation
Consulting on Regulatory Compliance Issues
Preparation for FDA inspections
Complaint and MDR systems
Manufacturing and software sections for submission
Responses and/or corrective action plans regarding FDA enforcement actions
Preparing Supplier Support Systems
Supplier selection, certification, and maintenance programs
Assessments of suppliers and contract manufacturers