Background

A pharmaceutical company preparing for product commercialization faced significant challenges in meeting FDA expectations. The organization lacked standard operating procedures (SOPs), had minimal supplier qualification controls, and was not adequately prepared for a Good Manufacturing Practice (GMP) inspection. A comprehensive evaluation of the company’s operational and quality infrastructure was necessary to ensure readiness for a successful FDA review and market entry.

RCA Approach

Regulatory Compliance Associates® Inc. (RCA) conducted a full Commercial Readiness Gap Assessment tailored to the FDA’s pre-approval inspection (PAI) framework. Key focus areas included:

• Evaluation of organizational structure and quality systems
• PAI readiness across six critical GMP subsystems
• Data integrity and Good Documentation Practices (GDP)
• Consumer complaint handling processes
• Oversight and qualification of third-party partners (CDMOs, laboratories, logistics providers
• Quality agreements and end-to-end supply chain traceability
• Internal QMS documentation gaps and procedures to support batch release
• Inspection preparedness through mock audits, training, and strategic planning

Result

Within just four weeks, RCA delivered a written, risk-based remediation roadmap that enabled the client to address high-priority compliance issues. The team identified and resolved critical GMP and supply chain gaps that could have resulted in regulatory findings during an inspection. RCA also supported the development of an interim Quality Unit (QU) and an inspection response team, ensuring organizational preparedness. As a result of this comprehensive engagement, the client was positioned to successfully pass their FDA pre-approval inspection without any major observations. RCA’s involvement continued post-launch, supporting the full build-out of a compliant, scalable Quality Management System (QMS).