Background

A life sciences company preparing for growth and regulatory scrutiny faced major deficiencies in its quality infrastructure. The organization lacked formal quality systems, had no established Quality Control Unit, and operated without investigation, CAPA, or change control processes. The supplier qualification program was informal and insufficient to meet compliance expectations. To support commercialization and strategic partnerships, the company required experienced QA leadership and scalable, remotely operated quality processes that could integrate seamlessly with manufacturing operations.

RCA Approach

Regulatory Compliance Associates® Inc. (RCA) deployed a cross-functional team of Quality Assurance and regulatory subject matter experts to rapidly build a compliant and sustainable quality framework. The engagement focused on establishing foundational QMS elements, including CAPA, change control, and deviation handling systems. RCA revised and updated QMS procedures to align with current GMP expectations and remediated weaknesses in supplier oversight by implementing robust supplier qualification SOPs. The team delivered remote GMP training to staff and built an inspection-ready document repository to support training traceability. RCA also implemented a cloud-based electronic Quality Management System (eQMS) for document control and supported the client’s executive team with risk mitigation plans for board-level presentations related to product compliance and commercialization.

Result

All remediation activities were completed within just eight weeks, allowing the company to close out a prior FDA Form 483 with no follow-up enforcement action. RCA’s support enabled rapid onboarding of internal QA resources and effective knowledge transfer, ensuring operational continuity. Most importantly, the client was positioned as a credible, quality-driven partner in the eyes of potential licensors and global regulatory agencies, strengthening its standing for future commercial approvals.