Compliance and Quality System

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.

CRC’s comprehensive quality assurance and compliance services include:

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

Designing and Conducting Customized Training Programs