Building a QMS for IMP Operations to Ensure GMP Compliance

This case study highlights how Rephine supported a fast-growing biotech company specialising in novel cancer biotherapeutics as it prepared to enter non-clinical and clinical trial phases. The company, recently spun out from two institutions, needed to establish a fully GMP-compliant Quality Management System (QMS) to support its Investigational Medicinal Product (IMP) operations.

Facing challenges such as a lack of internal GMP knowledge and key roles being managed by external consultants, the company required a flexible yet robust QMS tailored to its structure and regulatory needs. Rephine delivered a scalable system, embedded QA oversight, and ensured alignment across internal teams and outsourced partners—achieving full GxP readiness and preparing the client for regulatory inspections.

Download the full case study now and discover how Rephine helped a biotech company achieve GMP compliance for their IMP operations.