Quality Assurance & Compliance
At IreneMeds, we prioritize quality and regulatory excellence through a structured Quality Assurance and Compliance framework. Our team ensures that every clinical and operational process meets international standards such as ICH-GCP, ISO, and other regulatory guidelines. We focus on maintaining the integrity, reliability, and ethical conduct of all research activities.
Our Expertise Includes:
We conduct comprehensive internal and external audits to evaluate compliance with GCP, regulatory, and company standards. Our plant audits assess manufacturing and research facilities to ensure quality systems, data integrity, and operational efficiency meet global expectations.
We conduct comprehensive internal and external audits to evaluate compliance with GCP, regulatory, and company standards. Our plant audits assess manufacturing and research facilities to ensure quality systems, data integrity, and operational efficiency meet global expectations.
We create and implement Standard Operating Procedures (SOPs) that streamline operations and maintain consistency across all research and clinical processes. These SOPs are customized to align with organizational objectives, ensuring compliance and audit readiness at all times.
Our experts perform in-depth assessments to verify adherence to Good Clinical Practice (GCP) guidelines across all study sites. These assessments identify potential gaps and provide actionable recommendations to maintain the highest standards of ethical and scientific conduct.
We help organizations identify non-compliance issues and design robust corrective and preventive action (CAPA) plans. Our systematic approach ensures issues are resolved effectively, preventing recurrence and fostering a culture of continuous quality improvement.
