Read our case studies for real-world stories of project successes.
Learn how The FDA Group partnered with a large healthcare product Company to support a Pre-Approval Inspection (PAI) audit preparation project and subsequent quality system remediation efforts at a site within the European Union (EU).
Learn how The FDA Group partnered with a healthcare product Company to support a series of international Quality Audits to assess both Good Manufacturing Practices (GMP) and Good Clinical Practices (GCP) throughout the United States, Europe, Asia, and the Middle East.
Learn how The FDA Group supported a series of Risk Evaluation and Mitigation Strategy (REMS) Audits conducted in clinical inpatient pharmacies throughout the United States to evaluate product distribution processes for high-risk healthcare products and ensure those processes were being properly followed and data was effectively communicated to regulators.
Learn how The FDA Group planned and executed a comprehensive remediation project in response to Warning Letters issued to a large healthcare Company, integrating improvements into the Company’s Standard Operating Procedures while training staff in accordance with FDA expectations and monitoring the effectiveness of those improvements over time.
Learn how The FDA Group supported a large healthcare Company’s Quality & Regulatory Audit Project, uncovering significant quality issues and utilizing its staff of former FDA personnel to conduct specialized audits pertaining to Warning Letters and other high profile situations while empowering the Company to improve internal auditing procedures, quality system management, and record review processes.
Learn how The FDA Group has been working closely with a large healthcare Company to overcome a variety of compliance-related issues through comprehensive remediation, quality systems audits, extensive record review, ongoing CAPA improvements, new complaint handling protocols and updated Standard Operating Procedures.