IRAS Inc has extensive experience in creating effective quality systems and assisting in remediation plans. Most of the consultants in this field have a high level of quality management expertise

•  GxP Audits: evaluation of vendors, facilities, clinical sites, processes, quality systems and due diligence
•  Pre-Approval Inspections (PAI) readiness assessment followed by mock inspection
•  Development & implementation of comprehensive Quality Management  Systems including Quality Manual, Quality System SOPs & specific QS process SOPs
•  Quality Technical Agreement (QTA) Preparation
•  Quality risk management
•  Review of deviation investigations, change controls, validation reports, laboratory investigations, method validation reports
•  Root cause analysis and continuous improvement including CAPA program development
•  Assistance in remediating compliance issues such as FDA483 observations, Warning Letters, Complete Response Letters and Consent Decrees
•  Monitoring of product quality metrics and annual product reviews