Problems do arise. Pearl Pathways offers an experienced, responsive team of consultants to assist with all aspects of remediation. Whether you require documentation updates to reflect an as-built state or a complete process overhaul, our advisors will assess, develop a plan, work with appropriate regualtory bodies when necessary, and help you implement corrective and preventive actions (CAPA).


Our remediation services include:

  • Root cause analysis of audit or inspection reports for necessary corrective actions
  • Training and effectiveness checks
  • Process improvement
  • System/data analysis and augmentation
  • Organizational effectiveness
  • Validation services
  • Program management
  • Management of CAPA process
  • Gap analysis of existing quality systems and procedures against regulatory requirements and appropriate standards
  • Warning Letter & FDA Form 483 analysis, response, and remediation
  • Clinical site rescue and recovery
  • Creation of tailored training for employees to address gaps
  • Follow up audits